Regulatory Affairs Manager

Responsibilities: Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510... experience with FDA submissions (510(k), IDE, or PMA) and direct interaction with FDA reviewers. Solid understanding of U.S. FDA...

Lugar: San Francisco, CA | 16/11/2025 01:11:50 AM | Salario: S/. No Especificado | Empresa: Katalyst HealthCares & Life Sciences

Vice President, Quality Assurance

environments is mandatory Demonstrated experience in obtaining FDA approval for IDE/PMA and IND/NDA/BLA therapies is mandatory...

Lugar: Woburn, MA | 15/11/2025 03:11:29 AM | Salario: S/. No Especificado | Empresa: Sirtex