- Twist BioScience (South San Francisco, CA)
- …in a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices , IVD, EU ... at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs , Supplier Quality, Supply Chain, Quality Control,… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … more
- GRAIL (Menlo Park, CA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices . . **Global Regulatory ... regulatory initiatives focused on combination products and devices . Ensure regulatory conformance and consistency across...experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will consider other REGULATED Industry experience + ... focus on regulatory affairs . + 3+ years of related regulatory submission experience from a medical device and/or IVD industry. + Ability to work in a… more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...regulatory requirements for medical devices … more
- Abbott (Pleasanton, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… more
- Abbott (Pleasanton, CA)
- …budget and resources) by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical Affairs , ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure… more
- J&J Family of Companies (Santa Clara, CA)
- …Shockwave Medical social channels. + Work cross-functionally with product teams, medical affairs , legal, regulatory and compliance to ensure messaging ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
- ThermoFisher Scientific (South San Francisco, CA)
- …Clinical Practices is required. + 4+ years working in the In Vitro Diagnostic or Medical Device Industry; companion Diagnostic experience is a plus. + 4+ years ... **Location/Division Specific Information** This position is part of the Regulatory and Clinical Affairs organization which ensures...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Abbott (Santa Clara, CA)
- …Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry + ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Pleasanton, CA)
- …from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- J&J Family of Companies (Santa Clara, CA)
- …the requirements for sponsors involved in clinical investigations of medical devices . + Collaborate with quality and regulatory teams to maintain compliance ... and leadership of cross-functional teams to reach risk-based decisions in complex capital medical device product reviews. + Uses analytical skills and innovative… more
- J&J Family of Companies (Santa Clara, CA)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Professional Medical ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- Genentech (South San Francisco, CA)
- …early and late stage research and development of pharmaceutical products, digital health, and medical devices . As a member of the R&D Law Group, this **"Senior ... support Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs functions by providing strategic legal advice to… more
- Abbott (Santa Clara, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... can grow the career you dream of. + Free medical coverage for employees* via the Health Investment Plan...other departments including Global Clinical Operations, Research & Development, Regulatory Affairs , and Biostatistics. + Writes, study… more
