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.
Senior Regulatory Affairs Specialist PROCEPT BioRobotics CorporationSenior Regulatory Affairs SpecialistSan Jose, California$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.
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.
Senior Director, Regulatory Affairs (Oncology) Exelixis Inc.Senior Director, Regulatory Affairs (Oncology)Alameda, CA$248,000–$352,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience. Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteSan Jose, CARemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Director of Regulatory Affairs and Quality Assurance (RA / QA) Eight SleepDirector of Regulatory Affairs and Quality Assurance (RA / QA)San Francisco, CaliforniaEvery role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isn't passive, it's a powerful tool for living better. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies.
Director Of Regulatory Affairs And Quality Assurance (RA / QA) Eight SleepDirector Of Regulatory Affairs And Quality Assurance (RA / QA)San Francisco, CAEvery role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isn't passive, it's a powerful tool for living better. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies.
Director, Regulatory Affairs Nova Pneuma, Inc.Director, Regulatory AffairsFremont, CAPart timeManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Associate Director, Regulatory Affairs (on-site) AbbottAssociate Director, Regulatory Affairs (on-site)Alameda, CaliforniaThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAILDirector, Regulatory Affairs - Advertising, Promotional and Labeling #4810Sunnyvale, CA$189,000–$271,000 / yearThe Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
Senior Director, Regulatory Affairs Rems Program Cytokinetics, IncorporatedSenior Director, Regulatory Affairs Rems ProgramSouth San Francisco, CA$263,880–$307,860 / yearReporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution related to Risk Evaluation and Mitigation Strategy (REMS) and providing regulatory compliance oversight for REMS. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Regulatory Affairs Strategy Director Roth Staffing CompaniesRegulatory Affairs Strategy DirectorAlameda, California$133.33–$153.33 / hourBachelor's degree in related discipline and a minimum of thirteen years of related experience; or, · Master's degree in related discipline and a minimum of eleven years of related experience; or, · PhD degree in related discipline and a minimum of eight years of related experience; or, · Equivalent combination of education and experience. Leads the systematic collection, analysis, and dissemination of regulatory intelligence to proactively inform our client's policies, processes, and practices, enabling subject matter experts to assess the impact of evolving global regulatory requirements and translate regulatory changes into actionable guidance.
Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar ConsultingSenior Program Director (Commercial Regulatory Affairs, Fully Remote)South San Francisco, CaliforniaRemoteYou will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ".
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.
Director, Regulatory Affairs - US Filing Lead Revolution Medicines, Inc.Director, Regulatory Affairs - US Filing LeadRedwood 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.
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.
Sr. Regulatory Affairs TalentBurst, Inc.Sr. Regulatory AffairsSunnyvale, 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.
Sr. 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.
Regulatory Affairs Specialist AbbottRegulatory Affairs SpecialistPleasanton, California$73,900–$116,000 / yearAt 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 tomonitoringand treatment. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
(Senior) Manager, Regulatory Affairs Braveheart Bio(Senior) Manager, Regulatory AffairsSan Francisco, CaliforniaOur lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses.