- 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
- Sanofi Group (Morristown, NJ)
- …Device team is a globally diverse team supporting the medical device, combination product , digital health and in-vitro diagnostic ( IVD ) products within the ... management activities for device submissions/device aspects of medicinal product submissions + Liaises with device, clinical, manufacturing, commercial, and… 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 (San Juan, PR)
- …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
- Danaher Corporation (Minneapolis, MN)
- …for clinical quality and compliance. This includes study audit and inspection management activities across the Clinical Center of Excellence (CCOE). You will be ... a part of the Clinical Compliance team and report to the Sr. Director of Global Clinical Compliance responsible for clinical quality and scientific writing to… more