Arpit Mishra
Regulatory affairs Executive talk about | 510k USFDA 🇺🇸| EU MDR 🇪🇺| Latin America | GCC 🇸🇦 |ANVISA BRAZIL🇧🇷| Peru DIGEMID|PMS l CER | ISO 13485 Lead Auditor |SaMD Technical documents | Management consultant |
- Role
- Regulatory Affairs Executive at Auxein Medical
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Arpit Mishra
As a Senior Regulatory Affairs Specialist at Vantive, I focus on ensuring compliance with…
Experience
Regulatory Affairs Executive
Sep 2024 — Present · Delhi, IN
Preparing and handling dossiers for USFDA submissions (510(k), high-risk devices). • Ensuring compliance with EU MDR Annex I (GSPR) for high-risk class medical devices. • Managing Post-Market Surveillance (PMS) activities including PSUR & PMCF. • Leading CAPA investigations and implementing effective corrective/preventive actions. • Developing and maintaining Clinical Evaluation Reports (CERs). • Conducting Risk Management activities as per ISO 14971 standards. • Supporting and closing findings from internal audits and external audits (BSI, MDSAP). • Cross-functional collaboration with R&D, manufacturing, and quality teams for compliance. • Strong knowledge of global regulatory pathways (USFDA, EU MDR, MDSAP, ANVISA RDC,
Education
Shobhit University
Master of Technology - MTech, Biomedical/Medical Engineering
School Of Quality Management - India
ISO 13485, Auditing
Rajasthan University of Health Sciences, Jaipur
Bachelor of Pharmacy - BPharm, Medicine
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