Brian James
Director of Regulatory Affairs
- Role
- Director of Regulatory Affairs at Werfen North America
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
Experience
Director of Regulatory Affairs
Jan 2022 — Present
Education
UC Irvine
Certification, Regulatory Affairs Management
2010 — 2012
California State University, Northridge
BS Biotechnology with minor in Chemistry
2001 — 2006
UC Irvine
Certification, Medical Product Development
2010 — 2012
Skills
- Complaint Handling
- Glp
- Documentation
- Iso 13485
- Excel
- Regulatory Affairs
- Cgmp
- Gmp
- Quality Assurance
- Word
- Manufacturing
- Quality System
- Quality Systems
- Powerpoint
- Life Sciences
- Outlook
- Fda
- Compliance
- Complaint Management
- Biotechnology
- Medical Devices
- Capa
- Validation
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