Regulatory & QA Executive (Medical Devices)

Location : Marol, Mumbai Experience : 2–5 Years

Role Summary

Manage regulatory submissions and maintain the Quality Management System (QMS) to ensure products meet ISO 13485 standards and regulatory requirements (CDSCO, FDA, or MDR as applicable).

Key Responsibilities

• Regulatory Filings : Prepare and submit technical dossiers for device license approvals, renewals, and import / manufacturing licenses (e.g., MD-14 / MD-15 for India).
• QMS Maintenance : Manage SOPs, Change Controls, and CAPAs in strict compliance with ISO 13485 : 2016 .
• Risk Management : Assist in maintaining Risk Management Files in accordance with ISO 14971 .
• Audits : Conduct internal quality audits and assist during external regulatory inspections (Notified Bodies / Drug Inspectors).
• Post-Market Surveillance (PMS) : Track customer complaints and adverse events; prepare PMS reports.
• Labeling Compliance : Ensure IFUs (Instructions for Use) and packaging labels meet regulatory standards before release.

Requirements

Skills Required

Technical Documentation, Iso 14971, Word, Root Cause Analysis, Iso 13485, Excel