Glen Smythe
Head of Device Regulatory Affairs, Quality, and Compliance
- Role
- Head of Device Regulatory Affairs, Quality, and Compliance at Biogen
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
Experience
Head of Device Regulatory Affairs, Quality, and Compliance
Oct 2025 — Present
Education
South Dakota State University
Bachelor of Science - BS
Skills
- Iso 13485
- Regulatory Affairs
- Pma
- Iso 14971
- Regulatory Submissions
- Medical Devices
- Capa
- Premarket Approval (Pma)
- Regulatory Requirements
- Fda
- Quality System
- Medical Device Directive
- Design Control
- Ce Marking
- U.s. Food and Drug Administration (Fda)
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