Brett G.
- Role
- Senior Manager Regulatory Affairs at Thermo Fisher Scientific
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Brett G.
M.S. in QE & Management (2017). B.S. Biomedical Engineering, USC (2004) ASQ…
Experience
Senior Manager Regulatory Affairs
Apr 2022 — Present
Oversee a team of regulatory affairs professionals, focused on post-market activities including but not limited to global adverse event reporting, recall/FSCA coordination, customer notification reviews and approvals, and IVDR post-market surveillance implementation. Partner with global and divisional Quality Assurance to optimize processes and streamline global complaint handling initiatives.
Skills
- Cqe
- Clean Rooms
- Quality Operations
- Troubleshooting
- Iso 14971
- Heart Valves
- U.s. Food and Drug Administration (Fda)
- Iso 8
- Hardware Diagnostics
- Lean Six Sigma
- Fda Gmp
- Design of Experiments
- Mdr
- Biomedical Engineering
- Asq Member
- Design Control
- Vigilance
- Root Cause Analysis
- Orthopedic
- Capital Equipment
- Capa
- Cross-Functional Team Leadership
- Product Launch
- Medical Devices
- Regulatory Affairs
- Spine
- Lean Manufacturing
- Biotechnology
- Surgeons
- Manufacturing
- Dmaic
- Iso 13485
- Quality System
- Surgical Instruments
- Validation
- Fmea
- Surgery
- Fda
- Corrective and Preventive Action (Capa)
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