Job Summary:
We are seeking an experienced Regulatory Compliance Officer to ensure adherence to US FDA ( 21 CFR ), EU MDR / IVDR, and ISO 13485 standards.
The ideal candidate will manage regulatory submissions, oversee QMS compliance, and support audits / Inspections for medical devices.
Key Responsibilities: · Ensure compliance with FDA (21 CFR 820, Part 11), EU MDR/IVDR, and ISO · Prepare and submit 510(k), PMA, Technical Documentation, and CE Marking dossiers. · Maintain and improve the Quality Management System (QMS). · Conduct internal audits & support FDA / Notified Body inspections. · Perform risk management (ISO and post-market surveillance (PMS/Vigilance). · Stay updated on global regulatory changes ( FDA, EU MDR, UKCA, etc.). · Train teams on regulatory requirements.
Qualifications & Skills: · Bachelor's/Master's in Life Sciences, Biomedical Engineering, or Regulatory Affairs. · 3+ years in FDA/EU regulatory compliance ( medical devices ). · Hands-on experience with eCTD, STED, and regulatory submissions. · Strong knowledge of ISO 13485, ISO 14971, MDSAP. · Auditing experience ( lead auditor certification a plus ). · Excellent communication & documentation skills. Preferred Certifications: · RAC (Regulatory Affairs Certification) · CQE (Certified Quality Engineer) · Lead Auditor (ISO 13485)