Neelam Dangra
Deputy General Manager, Regulatory Affairs | Leading USFDA & MDR Submissions in the Medical Device Industry
- Role
- Deputy General Manager at Meril
- Location
- Valsad, GJ, IN
- LinkedIn followers
- 500 followers
About Neelam Dangra
Specialize in USFDA submissions for medical devices- Experienced in global regulatory submission development for countries like USFDA, Indian FDA (CDSCO), Europe,(Pre sub, Traditional 510k, Special 510k, CE Technical file, Design Dossiers) and to respond to the queries of the regulatory authorities - Experienced in preparation of CE technical dossier as per new regulation of EU MDR (prepared dossiers for Sirolimus eluting stent, Everolimus eluting stent, Transcatheter Heart Valve system)- Expertise in execution and documentation of the activities (viz. Bench testing, Shelf life studies, sample size planning, Biocompatibility etc.) required for regulatory submissions- Experienced in technical co ordination for FEA testing of medical devices- Experienced with GMP and ISO audits (internal and external)- Have a good knowledge of GMP and ISO 13485- Experienced in process validation as per GHTF guideline for medical devicesPlayed role in execution of Design History Files in accordance with FDA’s design control guidance - Experienced to communicate and coordinate with regulatory personnel of different companies for compilation of various documentations required for registration of their product meant to be imported in India- Experienced to assure a quality during R&D phase, to advise Product Development Team (PDT) on regulatory requirements, to support the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning- Skilled to be vigilant for regulatory changes being happened and their effect to our business- Expert in product registration, annual registration- ISO 14971:2019 certified
Experience
Deputy General Manager
Apr 2025 — Present
Education
K. B. Sumeria Commerce and Natraj Professional Science College
BSc - Bachelor of Science
Citec College London
Post Graduate
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