Tanmyee Gole
M.S (Pharm) Medical devices, Regulatory officer
- Role
- Regulatory Officer at Greens Surgicals Pvt. Ltd
- Location
- Nashik, MH, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Officer
Jun 2025 — Present · Vadodara, IN
As a Regulatory Officer, I support end-to-end regulatory compliance for orthopedic implants, ensuring adherence to international standards and national guidelines. My role includes preparing and reviewing regulatory submissions, coordinating with cross-functional teams, and maintaining documentation in alignment with ISO 13485, ISO 14971, and relevant regulatory frameworks.Key response:•Ensuring compliance with quality management systems (QMS), Good Manufacturing Practices (GMP), and risk management standards.•Supporting internal and external audits, addressing CAPAs, and maintaining regulatory documentation.•Monitoring regulatory updates and translating them into actionable compliance strategies for the organization.•Collaborating with R&D, QA, and production teams to ensure smooth regulatory clearance for new and existing products.
Education
MVP Samaj's College of Pharmacy, Nashik
Bachelor of Pharmacy - BPharm, Pharmacy
R.N.C. Arts, J.D.B. Commers, N.S.C. Science college of Nashik road
HSC, Science(PCMB)
National Institute of Pharmaceutical Education and Research - Ahmedabad
Master of Science - MS, Medical devices
2023
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