Senior Regulatory Affairs Specialist – Lingo (on-site) AbbottSenior Regulatory Affairs Specialist – Lingo (on-site)Alameda, California$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 Director & Therapeutic Area Head, Regulatory Affairs Revolution Medicines, Inc.Senior Director & Therapeutic Area Head, Regulatory AffairsRedwood City, CA$232,000–$290,000 / 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 regulatory strategy and leadership roles.
Director, Regulatory Affairs Companion Diagnostics (Cdx) Revolution Medicines, Inc.Director, Regulatory Affairs Companion Diagnostics (Cdx)Redwood City, CA$201,000–$251,000 / yearRequired Skills, Experience and Education: Advanced degree or bachelor's degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline with a minimum of 12+ years of pharmaceutical, biotechnology, diagnostics, or combination product experience, including at least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics. This individual will serve as the regulatory lead for companion diagnostic development programs, partnering closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Science, Commercial, and external diagnostic partners to ensure successful co-development and global registration of therapeutic products and associated companion diagnostics.
NewDirector of Regulatory Affairs Epia NeuroDirector of Regulatory AffairsAlameda, CaliforniaWe're looking for a Director of Regulatory Affairs, based in our Alameda, California office, to own the regulatory strategy and execution for Epia Neuro's Class III implantable neurotechnology - end-to-end, from early FDA engagement through IDE and PMA submission, approval, and commercialization. Partner directly with engineering on design and software decisions during active development, not reviewing after the fact, and help cross-functional alignment across development, clinical, quality, and operations to ensure activities support the regulatory strategy and requirements.
Manager, Regulatory and Market Affairs Pattern Energy Group LPManager, Regulatory and Market AffairsSan Francisco, California$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern’s existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern’s engagement in regulatory and market design changes, develop Pattern’s positions and execute on strategies to achieve desired objectives.
Public Policy Expert - Regulatory Affairs MercorPublic Policy Expert - Regulatory AffairsSan Francisco, CaliforniaRemote$50–$60 / hourInclude proposed and final rule text, regulatory impact discussion, and compliance determinations. A relevant credential or degree ( MPP , MPA , JD , CFCM/CPCM , PMP , or comparable).
Director, Regulatory Affairs - US Filing Lead Revolution MedicinesDirector, Regulatory Affairs - US Filing LeadRedwood City, California$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. 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 MedicinesDirector, Regulatory Affairs (US Filing Lead)Redwood City, California$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. 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.
Manager, Regulatory Affairs Noctrix HealthManager, Regulatory AffairsPleasanton, California$150,000–$180,000 / yearThe Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health’s medical devices.
Head of Regulatory Affairs Remedy RoboticsHead of Regulatory AffairsSan Francisco, CaliforniaExceptional written and verbal communication skills, with the ability to develop submission-quality narratives, present to executive leadership and boards, and effectively engage cross-functional technical stakeholders. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location.
Principal Regulatory Affairs Specialist – Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – Diabetes Care (on-site)Alameda, California$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. 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, California$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.
Director, Regulatory Affairs (Global Filing Lead) Revolution MedicinesDirector, Regulatory Affairs (Global Filing Lead)Redwood City, California$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. 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.
Regulatory Affairs Manager – Heart Failure (on-site) AbbottRegulatory Affairs Manager – Heart Failure (on-site)Pleasanton, California$114,000–$228,000 / yearAs an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. 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.
Sr. Manager, Regulatory Affairs VaxcyteSr. Manager, Regulatory AffairsSan Carlos, California$183,000–$194,000 / yearReports to: Executive Director, Regulatory CMC Location: US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Essential Functions: Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
Senior Director & Therapeutic Area Head, Regulatory Affairs Revolution MedicinesSenior Director & Therapeutic Area Head, Regulatory AffairsRedwood City, CaliforniaThe 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. 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 regulatory strategy and leadership roles.
Director, Regulatory Affairs Companion Diagnostics (CDx) Revolution MedicinesDirector, Regulatory Affairs Companion Diagnostics (CDx)Redwood City, CaliforniaThis individual will serve as the regulatory lead for companion diagnostic development programs, partnering closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Science, Commercial, and external diagnostic partners to ensure successful co-development and global registration of therapeutic products and associated companion diagnostics. Advanced degree or bachelor’s degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline with a minimum of 12+ years of pharmaceutical, biotechnology, diagnostics, or combination product experience, including at least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics.
Vice President, Regulatory Affairs Sight Sciences IncVice President, Regulatory AffairsMenlo Park, CA$291,720–$343,200 / yearPart timeProven leadership in compliance with an ability to troubleshoot within FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting. He or she should know regulatory road maps for medical devices and preferably combination drug-device products, which will speed up the clinical trial cycle, the regulatory process and garner more government resources.
Associate Manager - Medical Affairs LancesoftAssociate Manager - Medical AffairsFoster City, CA$50The USMA Manager of Virology Scientific Collaboration reports directly to the USMA Virology Scientific Collaboration, Director, and will serve as a point of contact for US Medical Affairs engagement with US external societies and medical scientific organizations, a cross-functional partner across USMA Virology with a focus on gastroenterology, hepatology or metabolic diseases. Works cross functionally within US Affiliate teams (USMA, Commercial, Legal and Medical Governance, Public Affairs and Government Affairs) on initiatives related to key external collaborations, projects, and working groups.
NewSr. Director, Clinical Affairs ShifamedSr. Director, Clinical AffairsLos Gatos, CaliforniaSupira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. This individual will own the operational, strategic, and cross-functional execution of the trial — from site activation through database lock — and will serve as the primary internal owner ensuring the study is executed on time, within budget, in full compliance with FDA and ISO 14155 requirements, and with the data integrity needed to support a successful PMA submission.