Regulatory Affairs and Quality Assurance professional with over 15 years of experience in the Medical Device industry. Proven track record in managing QMS processes, regulatory submissions, and compliance across FDA, EU MDR, and HC regulations. Successfully led multiple 510(k) clearances, CE markings, and MDSAP audits. Experienced in implementing eQMS and leading risk management processes. Certified ISO 13485:2016 Lead Auditor with a strong background in ISO 14971 and IEC 62304.