Regulatory & QA Executive (Medical Devices)

Location: Marol, Mumbai

Role Summary

ISO 13485

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.