- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… 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. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… 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
- 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
- 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
- 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 plus + ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...+ Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements… 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 strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… 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...fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our… more
- Gilead Sciences, Inc. (Foster City, CA)
- …directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years ... and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory ...or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory… 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 + ... and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , Product Performance Group (PPG), Sales and Marketing, Quality… more
- Abbott (Pleasanton, CA)
- …from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… 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
- J&J Family of Companies (Santa Clara, CA)
- …and leadership of cross-functional teams to reach risk-based decisions in complex capital medical device product reviews. + Uses analytical skills and innovative ... regulatory submissions by analyzing data, interpreting requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA, EU MDR, and… more
- Abbott (Pleasanton, CA)
- …budget and resources) by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical Affairs , ... a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure...data science teams and operating in a highly cross-functional medical device environment desirable. Global experience preferred.… more
- Stryker (Fremont, CA)
- …do:** **Technical Responsibilities:** + Works with Divisional Leadership, KOLs, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations ... internal stakeholders. + Works with Divisional Leadership, Marketing, Clinical Affairs and Regulatory Affairs and...desired):** **Preferred Skills** **/ Tools:** + Deep experience in medical device clinical research + 10+ years… more
- Genentech (South San Francisco, CA)
- …support Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs functions by providing strategic legal advice to ... with client groups, advising leaders in the R&D and Medical Affairs organizations, serving as a standing...and pragmatic solutions. + Experience with AI, advanced therapy medical products (ATMP), medical device … 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
- Abbott (Pleasanton, CA)
- …+ Two (2) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in medical device manufacturing or other similarly ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more