As an auditor from Navi Mumbai, Maharashtra, India, with 12+ years of experience in global medical device regulatory compliance, I have expertise in ISO 13485, MDSAP, and 21 CFR 820 documentation. My role involves supporting regulatory submissions in regions like India, EU, Canada, Brazil, Australia, and Japan. Previously, I served as Manager of Regulatory Affairs & PRRC at Veol Medical Technologies Pvt. Ltd., overseeing compliance for laparoscopic and gynecologic devices. Skilled in risk management and internal auditing, I ensure QMS implementation and handle clinical evaluation. My proficiency extends to change management, CE marking, and biocompatibility, making me a valuable asset in the medical device industry.