Regulatory & QA Executive (Medical Devices)
17 hours ago
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.
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