• Tuesday, March 02nd, 2010
VP of Quality Assurance & Regulatory Affairs
Location: Bay Area, CA
- Bachelors degree and preferably MBA
- 15+ years of experience in Medical Device QA/RA and clinical affairs.
- 10+ years of experience in and FDA Regulatory (ISO, MDD, QSR, CAPA…)
- ISO 13485 and 9000
- Hands-on experience with 510k Medical Device application processes.
- Medical Device Imaging / Diagnostics experience.
- Opto-Mechanical background is preferred.
- An established, relevant network within medical and healthcare technology.
- Must be highly motivated and self-directed.
- Excellent communication skills.