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.
NewEHS Specialist JobotEHS SpecialistWalnut, CA$75,000–$105,000 / yearThe team is looking for candidates who are skilled in conducting safety training, hazard analysis, incident investigations, hazardous waste management, environmental reporting, and maintaining compliance documentation, including SDS records, permits, and prevention plans. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
NewSenior BIM Specialist JobotSenior BIM SpecialistEmeryville, CA$105,000–$120,000 / yearThe firm provides innovative solutions across diverse markets, supporting technically complex projects that require regulatory rigor, cost control, schedule discipline, and creative structural design. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
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.
Senior Regulatory Affairs Specialist Lee Hecht HarrisonSenior Regulatory Affairs SpecialistDublin, CA$100,000–$150,000 / yearWe 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. This is a high-impact opportunity to work cross-functionally and contribute to product development and international market expansion.
NewPrincipal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CA$220,670–$259,610 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. What Your Day-To-Day Will Involve: Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT's products, marketing applications and post-market activities.
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 / yearCoordinate 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.
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.
NewStaff Regulatory Affairs Specialist Procept Biorobotics CorpStaff Regulatory Affairs SpecialistCAWhat Your Day-To-Day Will Involve: Act as a lead 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. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
NewSenior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Regulatory 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.
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.
Senior Regulatory Specialist AbbottSenior Regulatory SpecialistPleasanton, CaliforniaAt Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment. • As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
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.
Regulatory Affairs Specialist 4 IconmaRegulatory 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.
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 Volt Information Sciences IncSenior Regulatory Affairs SpecialistSanta Clara, CA$55–$59 / hourBuild 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.
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.
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.
Regulatory Affairs Specialist 3 - Multiport da Vinci Intuitive Surgical IncRegulatory Affairs Specialist 3 - Multiport da VinciSan Francisco, 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 HyperfineSenior Regulatory Affairs SpecialistPalo Alto, CA$145,000–$167,000 / yearHyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. 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.
Regulatory Affairs Specialist (NMPA) Intuitive Surgical IncRegulatory Affairs Specialist (NMPA)Sunnyvale, 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.
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.
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.
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.
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.
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.
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.
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 Consultant, Biologist/Regulatory Specialist, Power and Renewables ERM International Group LtdPrincipal Consultant, Biologist/Regulatory Specialist, Power and RenewablesWalnut Creek, CA$104,236–$156,352 / yearAs the largest global pure play sustainability consultancy, we partner with the world's leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues.
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.
Principal Consultant, Biologist/Regulatory Specialist, Power and Renewables ERMPrincipal Consultant, Biologist/Regulatory Specialist, Power and RenewablesWalnut Creek, California$111,000–$160,905 / yearAs the largest global pure play sustainability consultancy, we partner with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues.
Regulatory Specialist UCSF Medical CenterRegulatory SpecialistSan Francisco, CAThe UCSF Memory and Aging Center (MAC) is an internationally renowned clinical and translational research center with over 300 full time employees with offices and clinical research space located in the Sandler Neurosciences Building and multiple other buildings on the UCSF Mission Bay Campus. The regulatory specialist collaborates closely with principal investigators, study teams, study sponsors, and administrative offices to facilitate timely study activation and maintain ongoing regulatory compliance in a complex academic research environment.
Managing Technical Consultant, Permitting & Regulatory Specialist (Energy/Power/Renewable Projects) - California ERMManaging Technical Consultant, Permitting & Regulatory Specialist (Energy/Power/Renewable Projects) - CaliforniaWalnut Creek, California$93,050–$124,245 / yearAs the largest global pure play sustainability consultancy, we partner with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues.
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.
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).
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 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.
Business Development Specialist- Regulatory Covington & Burling LLPBusiness Development Specialist- RegulatorySan Francisco, CA$86,000–$112,000 / yearBusiness Development Specialist - Regulatory Marketing Department Summary We are seeking a results -oriented Business Development BD" Specialist to support the firms regulatory groups in marketing and developing new business. Reporting to the teams Assistant Director and managers for these groups the BD Specialist will deve lop knowledge and understanding of these practices and lawyers as well as the resources across the Marketing Department to collaborate on projects that secure new clients strengthen existing relationships and increase visibility of the practices.
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.
Regulatory Compliance Specialist - Remote MercorRegulatory Compliance Specialist - RemoteSan Francisco, CaliforniaRemote$80–$120 / hourFor details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome. Highly proficient in Microsoft Office and Google Workspace, especially Slides.
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.
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.
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 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.
Regulatory Affairs Coordinator Public Health Foundation Enterprises, InRegulatory Affairs CoordinatorRichmond, CAFull timeKnowledge of current Good ClinicalPractices (cGCP), current Good Manufacturing Practices (cGMP), Good Documentation Practices and a strong understanding of FDA regulations and guidelines. Participate in review of BabyBIG documentation to support highest possible quality of all records produced by manufacturing contractors or contracting research organizations .