- GRAIL (Menlo Park, CA)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... 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 is required.… more
- Twist BioScience (South San Francisco, CA)
- …at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs , Supplier Quality, Supply Chain, Quality Control, ... a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices, IVD, EU IVDR/MDR,… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies, for the designated program(s) to support clinical trials where necessary, and facilitate… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 6+ 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
- 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 (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… 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
- 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
- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar...device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality… 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 (Alameda, CA)
- …(MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott's Diabetes Care ... Minimum 8-10 years of experience in Quality Systems, Regulatory Affairs , or Quality Assurance within the medical device industry. * At least 5 years of… 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 (Milpitas, CA)
- …across business platforms as well as key cross-functional partners (eg, Global Strategic Marketing, Medical Affairs , Regulatory Affairs , R&D, etc.) to ... Equipment Platform Vision is an expert in ophthalmic and medical device research who is a core...Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents,… 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
