- 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
- Fujifilm (Helena, MT)
- …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