Regulatory Affairs Specialist DGN Technologies IncRegulatory Affairs SpecialistSunnyvale, CA$50–$60 / hourContractorp tabindex="0">• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. • Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
NewSenior Program Director, Commercial Regulatory Affairs - Contract TalentBurst, Inc.Senior Program Director, Commercial Regulatory Affairs - ContractSouth San Francisco, CA$120–$128.78 / hourExample Duties and ResponsibilitiesPRC Leadership: Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area. 4 or more years' previous experience leading large-scale, cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact strongly preferred.
NewSr. Regulatory Affairs - Contract TalentBurst, Inc.Sr. Regulatory Affairs - ContractSunnyvale, CAStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
NewBiospecimen Acquisition and Data Specialist - Contract TalentBurst, Inc.Biospecimen Acquisition and Data Specialist - ContractPleasanton, CA$46.40–$46.40 / hourFacilitate cross-functional alignment with local and global stakeholders, including Procurement, Legal, Safety, Quality, and Logistics (Import/Export). You have prior experience navigating a highly complex, global matrix environment to align cross functional stakeholders.
NewCompliance Specialist III JouléCompliance Specialist IIIMountain View, CA$25–$25 / hourThis role serves as a key liaison between customers, quality teams, regulatory functions, and cross-functional stakeholders to ensure timely processing, documentation, reporting, and communication related to field actions. Support audit readiness efforts by maintaining accurate documentation and providing information required for internal and external audits.
NewCare Specialist Upward HealthCare SpecialistAlameda, CA$21–$24 / hourOutcome-Oriented Approach: Focuses on achieving key health outcomes, such as improved care adherence, reduction in emergency room visits, and enhanced self-management. By building relationships, coordinating care, and providing education, the Care Specialist plays a critical role in promoting health, preventing unnecessary hospitalizations, and improving patient outcomes.
NewExecutive Director, US Medical Affairs, Oncology Solid Tumor Lead Jazz PharmaceuticalsExecutive Director, US Medical Affairs, Oncology Solid Tumor LeadPalo Alto, CARemote$304,000–$456,000 / yearThis role will be the strategic partner for the Oncology Solid Tumor Commercial Lead and collaborate extensively on the design and execution of deployment of field colleagues in support of the therapeutic space, including the design and execution of account-level cross-functional collaboration, quality engagement, field and payer value, evidence strategy and execution, and serve as an SME in compliant medical design. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewInventory Specialist Whole Foods MarketInventory SpecialistCampbell, CA$19.50–$30.20 / hourli>Provides excellent customer service, addresses needs of customers in a timely and effective manner and models suggestive selling techniques; answers phones and pages promptly and courteously. All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department.
Senior Regulatory Affairs Specialist Lee Hecht HarrisonSenior Regulatory Affairs SpecialistDublin, CA$100,000–$150,000 / yearp>We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy, submissions, and product lifecycle activities. To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy.
Regulatory Affairs Specialist 4 ICONMA, LLCRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements:Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Principal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearli>Coordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
NewRegulatory Affairs Specialist 4 - Mountain View, CA 94043 Amicis GlobalRegulatory Affairs Specialist 4 - Mountain View, CA 94043Mountain View, CA$56–$60Minimum 8 years of Regulatory Affairs experience within a medical device company (experience may be combined with a Regulatory Affairs Master's degree, such as a Master's in Regulatory Science). Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
Senior Regulatory Specialist AbbottSenior Regulatory SpecialistPleasanton, Californiadiv>Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree . • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements .Senior Regulatory Specialist Abbott LaboratoriesSenior Regulatory SpecialistPleasanton, CA$90,000–$180,000 / yearAn excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Our mission is to help people with heart failure survive and thrive. • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.Senior Regulatory Affairs Specialist Volt Information Sciences IncSenior Regulatory Affairs SpecialistSanta Clara, CA$55–$59 / hourp>Build your future with VoltVolt is immediately hiring for Senior Regulatory Affairs Specialist in Santa Clara CaliforniaAs a Senior Regulatory Affairs Specialistyou will Develops and implements programs and processes to ensure that company products are safe legal and meet or exceed customer expectations for compliance with nationalregionalglobal regulations. PAY RANGE AND BENEFITSPay Range 55 - 59 per hourPay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.Regulatory Affairs Specialist 4 IconmaRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourstrong>Why Should You Apply?Health Benefits. Referral Program.Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)Alameda, CaliforniaCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.Senior Regulatory Affairs Specialist - Lingo (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, CA$90,000–$180,000 / yearIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.Senior Regulatory Affairs Specialist ProSomnus IncSenior Regulatory Affairs SpecialistPleasanton, CADevelop and implement global regulatory strategies for medical device products (Class I-II as applicable) Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international registrations. This role is responsible for developing and executing global regulatory strategies, prepares and manages submissions and registrations, conducts regulatory gap assessments, and supports international market expansion efforts.Principal Regulatory Affairs Specialist Pulmonx CorpPrincipal Regulatory Affairs SpecialistRedwood City, CAPulmonx is a global leader in interventional pulmonology, providing minimally invasive technologies, planning tools, and evidence-based treatments for people living with severe emphysema and advanced chronic obstructive pulmonary disease (COPD), a progressive lung condition characterized by severe breathing difficulty that can significantly restrict daily activities and negatively impact quality of life. Manage the full lifecycle of domestic and international registrations across multiple products simultaneously, including Q-Subs, PMA modules/supplements, 510(k)s, IDEs, license renewals, and reportable changes; maintain global registration tracking for license status, expiration dates, and compliance obligations across all markets.NewRegulatory Affairs Specialist 3 - Multiport da Vinci Intuitive Surgical IncRegulatory Affairs Specialist 3 - Multiport da VinciSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.Senior Regulatory Affairs Specialist – Lingo (on-site) AbbottSenior Regulatory Affairs Specialist – Lingo (on-site)Alameda, CaliforniaIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.Regulatory Specialist Science CorpRegulatory SpecialistAlameda, CA$140,000–$185,000 / yearThis role will drive global regulatory strategies for our medical device and biologic products, guide cross-functional teams through complex regulatory pathways, and ensure our innovative technology reaches patients safely and efficiently. Spearhead rapid response efforts to regulatory agency communications, including deficiency letters, requests for additional information, and pre-submission feedback; drafting clear, persuasive responses while managing tight turnaround time.Senior Regulatory Affairs Specialist HyperfineSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearul>Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations:Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Ensure regulatory submissions are authored according to applicable requirements and guidelines (as assigned) including, but not limited to:US FDA 510(k) submissions.Regulatory Affairs Specialist (NMPA) Intuitive Surgical IncRegulatory Affairs Specialist (NMPA)Sunnyvale, CAp>Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.Senior Regulatory Affairs Specialist (Onsite/Remote) EBR Systems IncSenior Regulatory Affairs Specialist (Onsite/Remote)Sunnyvale, CARemote$115,500–$156,400 / yearReviews and approves document change orders, advertising and promotional material, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams and ongoing sustaining support. In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business.Senior Regulatory Affairs Specialist Intuitive Surgical IncSenior Regulatory Affairs SpecialistSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.NewSenior Regulatory Affairs Specialist LancesoftSenior Regulatory Affairs SpecialistSanta Clara, CA$43.80Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.Cancer Clinical Trials Regulatory Specialist 2 (Remote) Stanford UniversityCancer Clinical Trials Regulatory Specialist 2 (Remote)Stanford, CARemote$74,082–$143,544 / yearThe pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. The SCI is a prominent, dynamic, and complex Institute within the Stanford University School of Medicine and actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.Principal Regulatory Affairs Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearThis is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.Principle Regulatory Affairs Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrinciple Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.Principal Regulatory Affairs Specialist - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.Regulatory Affairs Specialist 3 Intuitive Surgical IncRegulatory Affairs Specialist 3Sunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.Staff Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearIn This Role, You Will: Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions. As a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercializationbalancing speed with compliance as we bring category-defining medical devices to market.Staff Regulatory Affairs Specialist - Pleasanton, CA CalyxoStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearAs a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market. Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions.Senior Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Vascular (on-site)Santa Clara, CAIf you provide content to customers through CloudFront, you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID: TwCqpv6BvTS-vlIXPJgAp7ukNfx9zn63Emu1GvSBFUGz6uk2CLaUZw.Principal International Regulatory Product Specialist - Diabetes Care (on-site) AbbottPrincipal International Regulatory Product Specialist - Diabetes Care (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC) Amazon.com IncSr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)Sunnyvale, CAActs as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors.Regulatory Intelligence Specialist Intuitive Surgical IncRegulatory Intelligence SpecialistSunnyvale, CAU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).Regulatory Compliance Specialist The Surplus Line Association of CaliforniaRegulatory Compliance SpecialistSan Ramon, California$77,000–$115,000Working with its members and the CDI, the Association assists its members’ compliance with California laws and regulations; helps maintain a healthy, fair, and competitive surplus line marketplace in California; and strives to protect the interests of California insurance consumers. Each year we review more than 1 million policy transactions, equip insurance brokers with compliance tools and continuing education courses, monitor the financial stability of global insurers and deliver data-driven insights that help the industry stay ahead of emerging risks.Specialist, Client Programs and Events SkaddenSpecialist, Client Programs and EventsPalo Alto, CaliforniaWhile the role will primarily focus on California-based events, it will also support programs and events in other Firm offices as needed, contributing to the Firm’s broader business development and client engagement initiatives and delivering a consistently high-quality event experience. As a member of the global events team, this individual will work closely with practice-aligned business development managers, attorneys, and colleagues across the department to ensure the seamless delivery of events of all sizes and formats.Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsCAYou will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today. In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.NewRegulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.NewSenior Program Director, Commercial Regulatory Affairs Integrated Resources, IncSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CACommercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for client s global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. " Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).NewSenior Program Director, Commercial Regulatory Affairs Compass ConsultingSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAProgram Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.NewSenior Program Director, Commercial Regulatory Affairs IT EngagementsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$100–$100Role: Senior Clinical Program Director, Commercial Regulatory Affairs (Contract role)Location: San Francisco, CAPosition SummaryCommercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Client's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).NewSenior Program Director, Commercial Regulatory Affairs Software Guidance & AssistanceSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$47.37–$127.86 / hourb> Responsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).Principal International Regulatory Product Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrincipal International Regulatory Product Specialist - Diabetes Care (on-site)Alameda, CAIf you provide content to customers through CloudFront you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID oQMSmMdag93U0tF6JuaDNwDM9MkzpH82GljciImZq5mNr9AKPKBXKQ.12345678910Similar Job SearchesRegulatory Manager Jobs in San Jose, CALegal Director Jobs in San Jose, CALaw Assistant Jobs in San Jose, CALegal Specialist Jobs in San Jose, CALegal Counsel Jobs in San Jose, CALegal Analyst Jobs in San Jose, CASenior Counsel Jobs in San Jose, CALegal Executive Jobs in San Jose, CALegal Attorney Jobs in San Jose, CARegulatory Specialist Jobs in San Francisco, CA
Senior Regulatory Specialist Abbott LaboratoriesSenior Regulatory SpecialistPleasanton, CA$90,000–$180,000 / yearAn excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Our mission is to help people with heart failure survive and thrive. • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Senior Regulatory Affairs Specialist Volt Information Sciences IncSenior Regulatory Affairs SpecialistSanta Clara, CA$55–$59 / hourp>Build your future with VoltVolt is immediately hiring for Senior Regulatory Affairs Specialist in Santa Clara CaliforniaAs a Senior Regulatory Affairs Specialistyou will Develops and implements programs and processes to ensure that company products are safe legal and meet or exceed customer expectations for compliance with nationalregionalglobal regulations. PAY RANGE AND BENEFITSPay Range 55 - 59 per hourPay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.
Regulatory Affairs Specialist 4 IconmaRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourstrong>Why Should You Apply?Health Benefits. Referral Program.
Regulatory Affairs Specialist 4 eTeam Inc.Regulatory Affairs Specialist 4Sunnyvale, CA$58–$59 / hourStrong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions. " Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)Alameda, CaliforniaCoordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.
Senior Regulatory Affairs Specialist - Lingo (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, CA$90,000–$180,000 / yearIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
Senior Regulatory Affairs Specialist ProSomnus IncSenior Regulatory Affairs SpecialistPleasanton, CADevelop and implement global regulatory strategies for medical device products (Class I-II as applicable) Prepare, compile, and support FDA regulatory submissions, including 510(k)s, De Novo submissions, Technical Documentation (EU MDR), CE Mark submissions, supplements, and amendments, and international registrations. This role is responsible for developing and executing global regulatory strategies, prepares and manages submissions and registrations, conducts regulatory gap assessments, and supports international market expansion efforts.
Principal Regulatory Affairs Specialist Pulmonx CorpPrincipal Regulatory Affairs SpecialistRedwood City, CAPulmonx is a global leader in interventional pulmonology, providing minimally invasive technologies, planning tools, and evidence-based treatments for people living with severe emphysema and advanced chronic obstructive pulmonary disease (COPD), a progressive lung condition characterized by severe breathing difficulty that can significantly restrict daily activities and negatively impact quality of life. Manage the full lifecycle of domestic and international registrations across multiple products simultaneously, including Q-Subs, PMA modules/supplements, 510(k)s, IDEs, license renewals, and reportable changes; maintain global registration tracking for license status, expiration dates, and compliance obligations across all markets.
NewRegulatory Affairs Specialist 3 - Multiport da Vinci Intuitive Surgical IncRegulatory Affairs Specialist 3 - Multiport da VinciSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Senior Regulatory Affairs Specialist – Lingo (on-site) AbbottSenior Regulatory Affairs Specialist – Lingo (on-site)Alameda, CaliforniaIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
Regulatory Specialist Science CorpRegulatory SpecialistAlameda, CA$140,000–$185,000 / yearThis role will drive global regulatory strategies for our medical device and biologic products, guide cross-functional teams through complex regulatory pathways, and ensure our innovative technology reaches patients safely and efficiently. Spearhead rapid response efforts to regulatory agency communications, including deficiency letters, requests for additional information, and pre-submission feedback; drafting clear, persuasive responses while managing tight turnaround time.
Senior Regulatory Affairs Specialist HyperfineSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearul>Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations:Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Ensure regulatory submissions are authored according to applicable requirements and guidelines (as assigned) including, but not limited to:US FDA 510(k) submissions.
Regulatory Affairs Specialist (NMPA) Intuitive Surgical IncRegulatory Affairs Specialist (NMPA)Sunnyvale, CAp>Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Senior Regulatory Affairs Specialist (Onsite/Remote) EBR Systems IncSenior Regulatory Affairs Specialist (Onsite/Remote)Sunnyvale, CARemote$115,500–$156,400 / yearReviews and approves document change orders, advertising and promotional material, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams and ongoing sustaining support. In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business.
Senior Regulatory Affairs Specialist Intuitive Surgical IncSenior Regulatory Affairs SpecialistSunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
NewSenior Regulatory Affairs Specialist LancesoftSenior Regulatory Affairs SpecialistSanta Clara, CA$43.80Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
Cancer Clinical Trials Regulatory Specialist 2 (Remote) Stanford UniversityCancer Clinical Trials Regulatory Specialist 2 (Remote)Stanford, CARemote$74,082–$143,544 / yearThe pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. The SCI is a prominent, dynamic, and complex Institute within the Stanford University School of Medicine and actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.
Principal Regulatory Affairs Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearThis is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Principle Regulatory Affairs Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrinciple Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CA$100,000–$200,000 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Principal Regulatory Affairs Specialist - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Regulatory Affairs Specialist 3 Intuitive Surgical IncRegulatory Affairs Specialist 3Sunnyvale, CACertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Staff Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearIn This Role, You Will: Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions. As a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercializationbalancing speed with compliance as we bring category-defining medical devices to market.
Staff Regulatory Affairs Specialist - Pleasanton, CA CalyxoStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearAs a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market. Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions.
Senior Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Vascular (on-site)Santa Clara, CAIf you provide content to customers through CloudFront, you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID: TwCqpv6BvTS-vlIXPJgAp7ukNfx9zn63Emu1GvSBFUGz6uk2CLaUZw.
Principal International Regulatory Product Specialist - Diabetes Care (on-site) AbbottPrincipal International Regulatory Product Specialist - Diabetes Care (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC) Amazon.com IncSr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)Sunnyvale, CAActs as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors.
Regulatory Intelligence Specialist Intuitive Surgical IncRegulatory Intelligence SpecialistSunnyvale, CAU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
Regulatory Compliance Specialist The Surplus Line Association of CaliforniaRegulatory Compliance SpecialistSan Ramon, California$77,000–$115,000Working with its members and the CDI, the Association assists its members’ compliance with California laws and regulations; helps maintain a healthy, fair, and competitive surplus line marketplace in California; and strives to protect the interests of California insurance consumers. Each year we review more than 1 million policy transactions, equip insurance brokers with compliance tools and continuing education courses, monitor the financial stability of global insurers and deliver data-driven insights that help the industry stay ahead of emerging risks.
Specialist, Client Programs and Events SkaddenSpecialist, Client Programs and EventsPalo Alto, CaliforniaWhile the role will primarily focus on California-based events, it will also support programs and events in other Firm offices as needed, contributing to the Firm’s broader business development and client engagement initiatives and delivering a consistently high-quality event experience. As a member of the global events team, this individual will work closely with practice-aligned business development managers, attorneys, and colleagues across the department to ensure the seamless delivery of events of all sizes and formats.
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsCAYou will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today. In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.
NewRegulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
NewSenior Program Director, Commercial Regulatory Affairs Integrated Resources, IncSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CACommercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for client s global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. " Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
NewSenior Program Director, Commercial Regulatory Affairs Compass ConsultingSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAProgram Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.
NewSenior Program Director, Commercial Regulatory Affairs IT EngagementsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$100–$100Role: Senior Clinical Program Director, Commercial Regulatory Affairs (Contract role)Location: San Francisco, CAPosition SummaryCommercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Client's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
NewSenior Program Director, Commercial Regulatory Affairs Software Guidance & AssistanceSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$47.37–$127.86 / hourb> Responsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
Principal International Regulatory Product Specialist - Diabetes Care (on-site) Abbott LaboratoriesPrincipal International Regulatory Product Specialist - Diabetes Care (on-site)Alameda, CAIf you provide content to customers through CloudFront you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID oQMSmMdag93U0tF6JuaDNwDM9MkzpH82GljciImZq5mNr9AKPKBXKQ.