Strategic Head of Quality Assurance and Regulatory Compliance with over 16 years of executive leadership experience across the Pharmaceutical, Nutraceutical, API, and Medical Device sectors. Expert in designing, implementing, and maintaining robust Quality Management Systems (QMS) compliant with ISO 13485 (Medical Devices) and USFDA (21 CFR Part 820) guidelines. Proven track record in integrating Pharmacovigilance(PV) and Post-Market Surveillance (PMS) systems to ensure comprehensive product safety and lifecycle management. Adept at bridging technical requirements with business goals to minimize regulatory risk, ensure global compliance, and accelerate product time-to-market.
