Shweta Sharma
Regulatory Affairs Professional & Leader | Medical Devices | Result Driven| Submission Writing | Major & Emerging Markets | Pre & Post-Market | Project & Program Management | EU MDR & EU MDD
- Role
- Senior Regulatory Program Manager at Medtronic
- Location
- Memphis, TN, US
- LinkedIn followers
- 500 followers
About Shweta Sharma
USA, EU and International Regulatory Submissions (eg: 510k, PMA, technical File), Custom devicesMedical Devices Regulatory Affairs EU MDRDesign Control Spine Orthopedics Biomedical Engineering Regulatory Strategy QSRProject managment in New Product Development & projects with regulatory emphasis
Experience
Senior Regulatory Program Manager
Feb 2023 — Present · US
Education
University of Memphis
MS, Biomedical Engineering
2004 — 2006
Jawaharlal Nehru Technological University
B.Tech, Biomedical Engineering
2000 — 2004
Skills
- 21 Cfr
- Spine
- Product Development
- Ce Marking
- Iso 13485
- Surgical Instruments
- Product Launch
- R&D
- Medical Devices
- Design Control
- Biologics
- Iso 14971
- Regulatory Affairs
- Orthopedic
- Biomedical Engineering
- Quality System
- Orthopedics
- Fda
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