Regulatory & QA Executive (Medical Devices)

Location: Marol, MumbaiExperience: 2–5 Years

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).

• 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.

• 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.