- Ascendis Pharma (Palo Alto, CA)
- …Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This role involves ... regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA,… more
- BeOne Medicines (Emeryville, CA)
- …formulation, analytical, manufacturing, QC, QA, etc.). * Experience in gene/cell therapy or/and medical device is a plus. * In-depth knowledge of ICH ... The individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions of the job:** * Lead, develop, and optimize… more
- Amgen (Washington, DC)
- …Labeling Strategy, and under the supervision of the Labeling Strategy Therapeutic Area Head for Inflammation and Rare Disease, the Regulatory Labeling Strategist ... Demonstrated experience with authoring, developing, and updating pharmaceutical, biotechnology, and/or device product labeling + Labeling or regulatory affairs… more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... and direct reports. + In conjunction with the Sr. Director/Product Support Head , imparts senior regulatory guidance and advice during issues management… more
- West Pharmaceutical Services (Walker, MI)
- …or industrial engineering **Work Experience** + Minimum 10+ years in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs, ... for combination medicinal products, investigational medicinal products (IMP) and medical device products and components moulded, assembled,...regulatory requirements such as 21CFR Part 820 for Medical Devices and 21CFR Part 210, 211… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …or other technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with ... technical product expertise (Design Assurance, Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated medical … more
- Novo Nordisk (Plainsboro, NJ)
- …with start-ups, technology companies, and other external partners across diagnostics, medical devices , digital health, digital therapeutics, and data analytics ... latest innovations and emerging technologies, including diagnostics, data, digital health solutions, medical devices , and precision health + Global Partnership +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …for the following quality functions: Quality Systems, Complaints, Product Quality Leaders, Device Quality, Annual Product Quality Report (APQR), IT Quality and Issue ... service quality across all operations; this role involves strategic planning, regulatory oversight and collaboration with cross-functional teams to identify and… more
- University of Colorado (Aurora, CO)
- …Associate Chief Medical Officers (ACMOs), relevant Department Chair (or Division Head , as appropriate) and concurrence from the UCH CNO (or designee) and/or UCH ... Associate Chief Medical Officers (ACMOs), relevant Department Chair (or Division Head , as appropriate) and concurrence from the UCH CNO (or designee) and/or UCH… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …provide innovative technologies that make a meaningful difference in people's lives. Our medical devices , software and related services are used worldwide to ... experience in Indirect/Direct Strategic Sourcing. + Experience Consulting or in Medical Device Industry. + Supplier performance management, contract negotiation,… more
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