Director, Regulatory Health GPT IncDirector, RegulatoryMenlo Park, CAWe recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children's, WellSpan Health, John Doerr, Rick Klausner, and others. We are building a new class of agentic AI that supports patients and healthcare stakeholders across the entire life sciences value chain including patient services, clinical trials, access, adherence, and HCP-facing workflows.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteSan Jose, CARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
Director, Regulatory CMC Calico Life Sciences LLCDirector, Regulatory CMCSouth San Francisco, CA$275,000–$280,000 / yearActing as a key partner to CMC and Quality, this role is responsible for the CMC content of all investigational and marketing applications, ensuring technical consistency and compliance across all stages of the product lifecycle, from early-stage development through commercialization. Calico's highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.
Associate Director, Regulatory CMC Vaxcyte IncAssociate Director, Regulatory CMCSan Carlos, CA$180,000–$210,500 / yearVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Our work together is guided by four enduring core values: RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
NewVice President, Global CMC Regulatory Revolution Medicines, Inc.Vice President, Global CMC RegulatoryRedwood City, CA$294,000–$367,000 / yearThe Opportunity: We are seeking an accomplished, strategic and execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM) Regulatory, to lead our global chemistry, manufacturing, and controls (CMC) regulatory strategy and execution across all development programs and commercial assets. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Associate Director, CMC Regulatory Revolution Medicines, Inc.Associate Director, CMC RegulatoryRedwood City, CA$186,000–$233,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. The Opportunity: As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products.
Senior Talent Acquisition Specialist Novotech Health Holdings Pte LtdSenior Talent Acquisition SpecialistSouth San Francisco, CA$110,000–$145,000 / yearThe ideal candidate will have a strong track record of recruiting for clinical research and clinical operations roles, including positions such as Clinical Research Associates (CRAs), Clinical Trial Managers, Clinical Project Managers, Clinical Research Coordinators, Regulatory Affairs professionals, Medical Monitors, Data Managers, Biostatisticians, and other clinical development professionals. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
Sr. RA Specialist Noah Medical CorpSr. RA SpecialistSan Jose, CA$109,000–$136,000 / yearOur incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. Strong knowledge of: FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements.
NewSafety Data Sheet Authoring Senior Specialist Becton Dickinson Medical DevicesSafety Data Sheet Authoring Senior SpecialistMilpitas, CaliforniaWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. This role serves as a Subject Matter Expert (SME) and works cross‑functionally to plan, implement, and manage Product Stewardship activities, with a strong focus on Global SDS Authoring, Hazard Communication, Poison Center Notification (PCN) and Dangerous Goods compliance.
Clinical Labeling Operations Specialist Dawar Consulting, Inc.Clinical Labeling Operations SpecialistSan Mateo, CAThe Labeling Operations Specialist coordinates the implementation of new clinical labeling and labeling updates across Regulatory Affairs, Quality Assurance, Supply Chain, project teams, and packaging sites worldwide. Coordinate global clinical labeling implementation with Regulatory Affairs, Quality, Supply Chain, PMs, and packaging sites.
Labelling Specialist Pride GlobalLabelling SpecialistCupertino, CAParticipate in design and change control processes to update labelling related to new product developments product changes or regulatory updates. • Leads the Instructions for Use (IFU) creation and ensures compliance to global regulatory requirements, completes labeling reviews to verify compliance of labeling, and implements IFU with cross functional teams.
HPLC Specialist Scientist II Biologics Drug Product Development AbbVie IncHPLC Specialist Scientist II Biologics Drug Product DevelopmentSouth San Francisco, CAThe Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. Education: Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline with typically 4-5 years (Scientist I) or 7+ years (Scientist II) of relevant industry experience Master's degree in a related discipline with typically 2 years (Scientist I) or 5+ years (Scientist II) of relevant industry experience.
Senior Quality Specialist AbbottSenior Quality SpecialistAlameda, CaliforniaCross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation, product development/clinical research, design control activities, complaints, and post market surveillance. General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks.
Senior Quality Specialist Abbott LaboratoriesSenior Quality SpecialistAlameda, CA$90,000–$180,000 / yearCross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation, product development/clinical research, design control activities, complaints, and post market surveillance. General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks.
Performance and Development Specialist Applied IntuitionPerformance and Development SpecialistSunnyvale, CaliforniaBachelor’s degree and 5+ years of experience in people operations, HR generalist, or people program management roles with demonstrated stakeholder management experience, ideally including performance management or L&D program ownership. Applied Intuition is headquartered in Sunnyvale, California, with offices in Washington, D.C. San Diego; Ft. Walton Beach, Florida; Ann Arbor, Michigan; London; Stuttgart; Munich; Stockholm; Bangalore; Seoul; and Tokyo.
Director of Regulatory Compliance HCA Healthcare IncDirector of Regulatory ComplianceSan Jose, CA$161,990.40–$242,944 / yearJob Summary and Qualifications You will be responsible for coordination and oversight of all regulatory survey participation activities, completion of all Joint Commission accreditation survey requirements and management of the accreditation survey process, and completion of all Good Samaritan Hospital survey requirements and management of the surveys You will be responsible for coordinating all survey activity and follow up for a CMS validation survey and will assist in coordinating accreditation surveys for specialty programs, such as the Stroke Certification or Total Joint Certification Programs In addition, you will support regulatory surveys for individual hospital services, such as the Laboratory, Blood Bank, Imaging Services, Risk Management, and Patient Care Services What qualifications you will need: 5 years hospital experience or the equivalent combination of education and experience working in Quality Improvement and Regulatory Compliance required Knowledge of applicable regulations in the field and governmental regulations with regard to healthcare marketing and public information required M.A. Referral services for child, elder and pet care, home and auto repair, event planning and more Consumer discounts through Abenity and Consumer Discounts Retirement readiness, rollover assistance services and preferred banking partnerships Education assistance (tuition, student loan, certification support, dependent scholarships) Colleague recognition program Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.
Regulatory Affairs Specialist II Thermo Fisher Scientific IncRegulatory Affairs Specialist IIFremont, CA$72,000–$96,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Regulatory Affairs Specialist III Thermo Fisher Scientific IncRegulatory Affairs Specialist IIIFremont, CA$90,900–$121,200 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Statistician, CMC (Chemistry, Manufacturing, and Controls) Orca Biosystems IncStatistician, CMC (Chemistry, Manufacturing, and Controls)Menlo Park, CAThe successful candidate will partner closely with Analytical Development, Process Development, and Validation teams to design studies, analyze complex data (including non-normal distributions common in biologics assays), and translate results into clear, regulatory-defensible conclusions that support process and product decisions across the product lifecycle. Provide statistical support for analytical method validation and verification, including accuracy, precision, linearity, range, and robustness studies, with particular expertise in handling non- normal and skewed data through transformation strategies and non-parametric methods.
Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) Nurix Therapeutics, Inc.Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)Brisbane, CA$232,000–$274,000 / yearThis role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Compliance Specialist III System OneCompliance Specialist IIIMountain View, CaliforniaSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Assist with internal and external audits (e.g., FDA, ISO), including preparation, documentation, and follow-up actions .
Senior Regulatory Affairs Specialist PROCEPT BioRobotics CorporationSenior Regulatory Affairs SpecialistSan Jose, CaliforniaIt 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.
Staff Regulatory Affairs Specialist - Pleasanton, CA CalyxoStaff Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$160,000–$175,000 / yearMaster's degree with a minimum of 8 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 10 years of directly relevant regulatory affairs experience, in the medical device, biotechnology, or in vitro diagnostics (IVD) industry, including substantial experience with Class II or Class III electromechanical medical devices. 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 commercialization—balancing speed with compliance as we bring category-defining medical devices to market.
Senior 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 4 Iconma LLCRegulatory Affairs Specialist 4Sunnyvale, CARequirements: 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.
Regulatory Affairs Specialist II The Clorox CoRegulatory Affairs Specialist IIPleasanton, CA$90,900–$170,100 / yearThis role requires strong cross-functional collaboration, working daily with partners across R&D (e.g., Product Development), Product Safety, Legal, Corporate Quality, Government Affairs, and Consumer Affairs. Work with Consumer Affairs to develop consumer-facing responses, providing regulatory guidance to ensure accuracy, consistency, and appropriate interpretation of product claims, ingredients, and safety information.
Training Specialist Sr. AxelonTraining Specialist Sr.Alameda, CASUMMARY This role designs the training interventions required to execute the organizations learning strategy, ensuring employees and BPO partners have the skills needed to support Clients Client products, technical troubleshooting, compliance/complaint handling, customer service, and quality assurance behaviors. The role partners with subject matter experts across Client to design, implement, evaluate, and administer global Customer Experience training programs delivered through a mix of documentbased, video/audio, and interactive media formats.
Regulatory Operations Specialist - Temporary Twist Bioscience CorpRegulatory Operations Specialist - TemporarySouth San Francisco, CA$31–$42 / hourThe Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required.
Senior 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 Submission Publishing Specialist Pride GlobalRegulatory Submission Publishing SpecialistPleasanton, CARemote$24.51–$36.54 / hourProficiency with Microsoft Word, Adobe Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals, and other publishing tools. Coordinate with Regulatory Affairs teams and project stakeholders to ensure timely submissions.
Director, Regulatory Affairs (US Filing Lead) Revolution Medicines, Inc.Director, Regulatory Affairs (US Filing Lead)Redwood City, CA$211,000–$264,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Senior Program Director, Commercial Regulatory Affairs LancesoftSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$129.714 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. Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction.
Digital Science Content Specialist Anatomage, Inc.Digital Science Content SpecialistSanta Clara, CA$70,000–$83,000 / yearAnatomage offers 3D software for anatomy and physiology education including a life-sized virtual dissection platform and with our latest technology the Science Table that includes virtual lab experiments in Biology, Chemistry, and Physics. This person will be an integral part of the team, working alongside a group of subject matter experts and developers who have an impact on the educational resources that we provide.
Digital Biology Specialist Anatomage, Inc.Digital Biology SpecialistSanta Clara, CA$80,000–$100,000 / yearWith a diverse group of people from various technical, clinical, and artistic backgrounds, Anatomage provides a culture where distinguished individuals can work and collaborate in an organic manner. This person will be an integral part of the team, working alongside a group of subject matter experts who have an impact on our educational resources that we provide.
Sr Manager/Assoc Director, CMC Regulatory Affairs Erasca IncSr Manager/Assoc Director, CMC Regulatory AffairsSouth San Francisco, CA$175,000–$205,000 / yearAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Position Responsibilities: Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
Partnership Development Specialist - Business Development Unitek Learning IncPartnership Development Specialist - Business DevelopmentSouth San Francisco, CA$70,000–$80,000 / yearYou will represent Unitek in the community, establish long-term relationships with clinical education leaders and healthcare decision-makers, and clearly communicate how partnering with Unitek benefits their organization, their patients, and the future healthcare workforce. Minimum Requirements: Two or more years of experience in sales, outside sales, business development, recruiting, account management, client relations, workforce development, employer relations, healthcare partnerships, or a comparable relationship-based role is preferred.
Payroll and Benefits Specialist SurefoxPayroll and Benefits SpecialistSunnyvale, CaliforniaWe welcome all candidates who share the same passion for protection services and providing our employees with exceptional Payroll and benefits service and encourage military veterans and candidates currently in the military reserve to apply. Leave Administration: Independently manage leave processes from initial notice to return-to-work, including FMLA, Military Leave, Short-Term Disability, and state-specific leaves.
Head Of Regulatory Affairs Health GPT IncHead Of Regulatory AffairsMenlo Park, CAHelp design, support, and maintain a compliant regulatory framework and Pharma-partner guidelines, including iterative AI development, model updates, QMS and GMP requirements, audits and inspections, real-world performance, and post-market monitoring and mitigation. We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children's, WellSpan Health, John Doerr, Rick Klausner, and others.
Customs Specialist Flexport IncCustoms SpecialistSan Francisco, CABecome a global trade expert by navigating the complex world of customs regulations to ensure goods comply with international laws. Depending on your location, the General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA) may regulate the way we manage the data of job applicants.
Senior 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.
Principal Regulatory Affairs Specialist Procept Biorobotics CorpPrincipal Regulatory Affairs SpecialistSan Jose, CAIt 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.
Regulatory Affairs Specialist 4 ICONMA, LLCRegulatory Affairs Specialist 4Sunnyvale, CA$55–$60 / 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 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.
Senior Specialist - Medical Events Group AbbottSenior Specialist - Medical Events GroupAlameda, California$90,000–$180,000 / yearGeneral Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks. This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
Medical Events Group Specialist I (Operations) AbbottMedical Events Group Specialist I (Operations)Alameda, California$81,500–$141,300 / yearGeneral Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks. Coordinate cross-functional inputs and align with leadership to develop accurate, compliant responses to inquiries from Competent Authorities, Notified Bodies, commercial affiliates, and internal teams.
NewSr. Regulatory Affairs Specialist JouléSr. Regulatory Affairs SpecialistMountain View, CA$55–$60 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
Senior Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncSenior Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$145,000–$160,000 / yearRequirements: Master''s degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor''s degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry, including experience with Class II or Class III electromechanical medical devices. In This Role, You Will: Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables.
NewRegulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 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). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
Senior Regulatory Affairs Specialist Hyperfine IncSenior 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. Key Responsibilities: 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.
Client Support Specialist - Greater San Jose, CA Area (REMOTE) FidelityClient Support Specialist - Greater San Jose, CA Area (REMOTE)San Jose, CaliforniaRemotePlease be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Engage with customers, via inbound calls, responding to their inquires which may include providing product and service level guidance, processing transactions to include options, equities, mutual funds and fixed income trades and other specialized monetary requests.