Anuja Pawar
Regulatory Affairs Executive | EU- MDR | FDA 510(k) | ISO 13485 | ISO 14971 | Medical Devices & Pharma
- Role
- Regulatory Affairs Executive at Meril
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Anuja Pawar
Regulatory Affairs professional with hands-on experience in medical device and pharmaceutical regulatory compliance. Currently working as a Regulatory Affairs Executive at Meril Lifesciences, supporting EU-MDR and US FDA 510(k) documentation across the product lifecycle.Experienced in preparing and maintaining technical documentation, Risk Management Files (ISO 14971), usability engineering documentation (IEC 62366-1), labeling and IFUs, SOP authoring, and regulatory change management. Actively involved in coordinating external audits and regulatory inspections while ensuring continuous compliance with evolving regulations, standards, and MDCG guidance.Previously worked with Glenmark Pharmaceuticals and Macleods Pharmaceuticals, gaining strong exposure to USFDA, ICH, GMP, and GLP-compliant documentation, audit preparedness, and data integrity. Known for strong attention to detail, cross-functional collaboration, and the ability to translate complex technical data into compliant regulatory documentation.Core Competencies:EU-MDR | FDA 510(k)| ISO 13485 | ISO 14971 | IEC 62366-1 | Labeling & IFU | SOPs | Audit Support | Regulatory Documentation
Experience
Regulatory Affairs Executive
Nov 2025 — Present
Prepare, compile, and update technical documentation in compliance with EU-MDR and US FDA 510(k) requirements.Develop and maintain Risk Management Files and Usability Engineering documentation in accordance with ISO 14971 and IEC 62366-1.Prepare and review labeling, IFUs, surgical techniques, and promotional materials for regulatory compliance.Draft, review, and update SOPs, recommending changes to maintain regulatory compliance.Monitor changes in regulations, standards, and MDCG guidance, ensuring timely implementation.Coordinate and support external audits and regulatory inspections, including closure of observations.
Education
Bombay College Of Pharmacy
Master of pharmacy, pharmaceutical Analysis
2019 — 2021
Sinhgad Technical Education Societys Smt. Kashibai Navale College of Pharmacy, .,Dist.Pune 48
Bachelor of Pharmacy - BPharm
2015 — 2019
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