- GRAIL (Menlo Park, CA)
- …years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD , medical device, or pharmaceutical industries. + ... Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product … more
- Danaher Corporation (West Sacramento, CA)
- …with diagnostic tools that address the world's biggest health challenges. The Director , PMO, Microbiology for Beckman Coulter Diagnostics is responsible for leading ... cross-functional teams to deliver major programs within the Microbiology product lines, from business case development through product launch and transition to… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …and lead implementation and execution of CDx assays (from study conduct, sample management testing to launch) in collaboration with partners/ IVD Sponsors and ... We are seeking a Director to join our Precision Medicine team. The...the relevant inputs + Develop strong relationships partnerships with IVD partners and testing laboratories + Oversee operational aspects… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …research tools to laboratory professionals, clinicians, and clinical/life science researchers. The Director will serve as a key technical leader for new, flow ... understand R&D requirements but also to possess an in-depth knowledge of product characterization, verification and validation activities, as well as the regulatory… more
- Abbott (San Diego, CA)
- …location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US ... working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, CA**… more
- Fujifilm (Boston, MA)
- …Risk Biomarkers sales through that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a comprehensive ... and maintaining key customer database. + Demonstrate competency with key account management , best practices, and selling skills. + Liaise with office and laboratory… more
- Danaher Corporation (Richmond, IL)
- …to develop regulatory affairs skills. This position reports to the Director , Quality Assurance and Regulatory Compliance ( Management Representative) and ... Leica Biosystems is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and… more
- Danaher Corporation (Richmond, IL)
- …including QC finished goods and raw material inspection program, QA product release, nonconformance workflows, CDT&R, and calibration. This position reports to ... the Director , Quality Assurance and Regulatory Compliance responsible for ensuring...and Regulatory Compliance responsible for ensuring that the business, product , and processes meet all Quality and Regulatory standards… more