Priyanka More
Regulatory Affairs at Abbott HealthCare PVT LTD | IVDs | Certified in Effective Implementation and Internal Audit of ISO/IEC 13485:2016 Medical Devices Management System
- Role
- Regulatory Affairs Specialist at Abbott
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Priyanka More
To ensure the timely submission & approvals of import licenses for Class A, B, C&D (IVD) products, within the Indian regulatory system-Central Drugs Standard Control Organisation (CDSCO_National regulatory body for Indian pharmaceuticals). To comply UDI implementation for all regulated products as per MDR, 2017. Process development- to draft SOPs for new regulatory procedures.4. Variations/Post-approval changes and regulatory functions for global regulatory filings.5. Waste Management- to ensure products for destruction to be handled and destroyed in compliance with established rules for waste management.6. Certified in Effective Implementation and Internal Audit of ISO/IEC 13485:2016 Medical Devices Management System.7. Skilled in Regulatory Submissions/ Validation, Life Cycle Management, Clinical/Non-Clinical Documents Publishing, Publishing Tools, CRF Submissions, Copyright Clearance Activity for Authors to Publish.Well versed with Microsoft office, ISI Toolbox/Publisher, Adobe Reader, Lorenz Publisher/eValidator.8.Experienced in Social Media and media PR. MSc. in Biotechnology from Mumbai University.
Experience
Regulatory Affairs Specialist
Sep 2020 — Present · Mumbai, IN
Dedicated Regulatory Affairs Professional with a proven track record in orchestrating seamless submissions of product licenses and renewals/retention within the stringent framework of the Indian regulatory landscape, specifically under CDSCO and various other regulatory authorities. Expertise extends to managing variations, post-approval changes, and regulatory functions for filings products to be imported to India. Adept in navigating complexities, ensuring compliance with MDR 2017, including various regulatory requirements, labelling regulations and supporting EHS with sustainable initiatives in E-Waste, Battery Waste and Plastic Waste Management for Abbott Core Diagnostics Platforms (IVDs).
Education
Pillai College of Arts,Commerce and Science
Master of Science (M.Sc.)
2013 — 2017
University of Mumbai
Masters of Science (M.Sc)
2015 — 2017
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