Priyanka More
Regulatory Affairs Professional ||Ex Abbott || Ex TCS | IVDs | MDs_ Certified in Effective Implementation and Internal Audit of ISO/IEC 13485:2016 Medical Devices Management System
- Role
- Regulatory Affairs Manager at Transasia Bio-Medicals Ltd.
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Priyanka More
Regulatory Affairs professional with over six years of experience in the medical device and IVD industry, specializing in CDSCO compliance, global regulatory filings. I have successfully led import license approvals (Class A, B, C&D), post-approval variations (MDR 2017), and adherence to environment regulations to streamline regulatory operations.Certified in ISO 13485:2016 Internal Audits, I ensure seamless compliance while managing waste management regulations, product life cycle, and risk-based regulatory strategies. My expertise extends to regulatory submissions, document publishing, and copyright clearance.Committed to regulatory excellence, patient safety, and market access, I thrive on navigating complex regulatory landscapes to support healthcare innovation.Let’s connect to exchange insights on global regulatory trends, compliance strategies, and industry best practices.#RegulatoryAffairs #MedicalDevices #IVD #CDSCO #ISO13485 #Compliance #GlobalRegulations
Experience
Regulatory Affairs Manager
Sep 2025 — Present · Mumbai, IN
Education
Pillai College of Arts,Commerce and Science
Master of Science (M.Sc.), Biotechnology microbiology biochemistry
2013 — 2017
University of Mumbai
Masters of Science (M.Sc), Biotechnology
2015 — 2017
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