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 Education : B.Tech (Biomedical), B.Sc. Clinical Research, or similar

Core Knowledge : Strong grasp of ISO 13485 (QMS) and ISO 14971 (Risk). Familiarity with Indian Medical Device Rules (IMDR 2017) or EU MDR is highly preferred.

Skills : Technical documentation, root cause analysis, and proficiency in Excel / Word.

Traits : Detail-oriented with a zero-error approach to compliance.