Kristi Frisch
Principal Regulatory Affairs Specialist, Arthrex
- Role
- Regulatory Affairs Specialist, Principal at Arthrex
- Location
- Naples, FL, US
- LinkedIn followers
- 500 followers
ScienceView LinkedIn profile
Experience
Regulatory Affairs Specialist, Principal
Nov 2022 — Present
Skills
- Iso 14971
- Iso 13485
- Quality System
- V&V
- U.s. Food and Drug Administration (Fda)
- Regulatory Submissions
- Regulatory Requirements
- Pma
- Clinical Trials
- Orthopedics
- Fda
- 21 Cfr
- Gmp
- Validation
- 21 Cfr Part 11
- Corrective and Preventive Action (Capa)
- Ce Marking
- Design Control
- Biomedical Engineering
- Medical Devices
- Clinical Research
- Capa
- Regulatory Affairs
- Orthopedic
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