Somasharan Kale
Medical Device | Regulatory Affairs | IMDR, 2017 | ISO 13485 QMS | ISO 14791 RMF |UK-MDR | EU-MDR 2017/745 | e-QMS | Global Complaint Handling.
- Role
- Regulatory Affairs Coordinator at Clinisupplies
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Coordinator
Oct 2024 — Present · Bangalore, IN
Regulatory Submission UK MDR & EU MDR, e-QMS and Global Complaint Handling.GRN release to review Quality Documents.Monthly & Quarterly Activity - Report preparation. Technical File & PMS preparation as per regulatory requirements.
Education
D.S.T.S Mandal's College of Pharmacy Solapur
Master of Pharmacy ( Quality Assurance)
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