Ankit Shah
- Role
- Senior Regulatory Affairs Manager at Spectrawave, Inc
- Location
- Shelby County, TN, US
- LinkedIn followers
- 500 followers
Healthcare & Human ServicesView LinkedIn profile
About Ankit Shah
Specialties: Regulatory Affairs: 510(k), PMA, IDE, CE Marking, Canadian Licensing…
Experience
Senior Regulatory Affairs Manager
Aug 2023 — Present
Education
University of Southern California
Master’s Degree, Medical Device and Diagnostics-Regulatory Affairs & Quality Assurance
2008 — 2010
University of Memphis
Master of Business Administration (M.B.A.)
2016 — 2019
University of Mumbai
Bachelors, Biomedical Engineering
2004 — 2008
Skills
- Biomedical Engineering
- Auditing
- Capa
- Validation
- Regulatory Submissions
- Fda
- U.s. Food and Drug Administration (Fda)
- Iso 14971
- 510 (K)
- Regulatory Affairs
- Quality System
- Iso 13485
- Ce Marking
- Medical Devices
- Regulatory Requirements
- 21 Cfr
- Standard Operating Procedure (Sop)
- V&V
- Six Sigma
- Cross-Functional Team Leadership
- Custom Device
- Pma
- Custom Devices
- Design Control
- Microsoft Office
- Corrective and Preventive Action (Capa)
- Quality Assurance
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