Regulatory, Quality & Distribution Operations (Medical Devices)

**Job Profile – Regulatory, Quality & Distribution Operations (Medical Devices)**

Ensure end-to-end compliance with **ISO 13485:2016** , **Medical Devices Rules, 2017** , and **Drugs and Cosmetics Act, 1940** across warehouse and distribution operations. Maintain audit-ready documentation and regulatory certifications to support internal, external, and authority inspections. Drive implementation and governance of **Good Distribution Practices (GDP)** for medical devices, ensuring product integrity throughout the supply chain. Manage Quality Management System (QMS) processes including Change Controls, Deviations, CAPAs, and Non-Conformances. Ensure complete product traceability through accurate documentation (invoices, delivery challans, batch/lot tracking, stock records). Oversee inventory governance by enforcing **FIFO/FEFO** , cycle counts, and reconciliation to achieve 100% inventory accuracy. Coordinate with QA for product release, incoming inspections, and pre-disp...