- GRAIL (Menlo Park, CA)
- The Associate Director , Safety & Data Integrity Operations will partner with the Head of Safety, & Data Integrity Officer to develop and deploy a robust Safety & ... Data Integrity program at GRAIL. The Associate Director will work cross-functionally to implement...in any of the following industries (preferred): direct In Vitro Diagnostic , medical device or pharma industry.… more
- GRAIL (Durham, NC)
- …clinical studies and to support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director will work ... years experience in any of the following industries: direct In Vitro Diagnostic , medical device or pharma industry. + Experience supporting regulatory… more
- Sanofi Group (Swiftwater, PA)
- …diverse team supporting the medical device, combination product, digital health and in- vitro diagnostic products within the Sanofi portfolio of products. The ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. **Position Overview:** Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …MDR/IVDR experience. + History of successful 510(k) clearances and/or PMA approvals of in vitro diagnostic devices is a plus. + Flow cytometer experience a plus. ... + Premarket Experience: Experience supporting medical device regulatory submissions; proven experience with application of quality and regulatory requirements for IVD manufacturers in the design and development of medical devices. listings, establishment… more