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.
NewSenior 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. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US.
Senior Regulatory Affairs Specialist – Heart Failure (on-site) AbbottSenior Regulatory Affairs Specialist – Heart Failure (on-site)Pleasanton, CaliforniaThe individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. At 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.
Manager, Regulatory Affairs Noctrix HealthManager, Regulatory AffairsPleasanton, CA$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.
Director, Regulatory Affairs (US Filing Lead) Revolution MedicinesDirector, Regulatory Affairs (US Filing Lead)Redwood 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 a regulatory strategy role.
Director, Regulatory Affairs - US Filing Lead Revolution MedicinesDirector, Regulatory Affairs - US Filing LeadRedwood 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 a regulatory strategy role.
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, 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 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, California$201,000–$251,000 / yearThis 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.
NewSr. Director, Clinical Affairs Shifamed LLCSr. Director, Clinical AffairsLos Gatos, CA$200,000–$230,000 / yearSupira 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.
Global Head of Government Affairs ZiplineGlobal Head of Government AffairsSan Francisco, CA$250,000–$300,000 / yearYou'll design and execute Zipline's government affairs and public affairs strategy, with the support of the world-class team you build and lead, and you'll have a direct impact on scaling Zipline's business across the United States, building on our broad footprint in Africa, and launching new markets abroad. Develop and maintain networks of community advocates, including business and civic leaders, former public officials, users and merchants, first responders, academics, faith leaders, healthcare organizations, environmental and road-safety groups, and workforce organizations.
Director, Clinical Affairs Noctrix HealthDirector, Clinical AffairsPleasanton, CA$240,000–$280,000 / yearThis individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation. The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners.