Regulatory Compliance Officer
Posted 1 week ago by KoKo PFT Limited
Negotiable
Undetermined
Undetermined
Waltham Abbey, England, United Kingdom
Summary: The Regulatory Compliance Officer will be responsible for ensuring compliance with US FDA, EU MDR/IVDR, and ISO 13485 standards within the medical device sector. This role involves managing regulatory submissions, maintaining the Quality Management System, and supporting audits and inspections. The ideal candidate will have a strong background in regulatory compliance and experience in training teams on regulatory requirements.
Key Responsibilities:
- Ensure compliance with FDA (21 CFR 820, Part 11), EU MDR/IVDR, and ISO 13485.
- 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 14971) and post-market surveillance (PMS/Vigilance).
- Stay updated on global regulatory changes (FDA, EU MDR, UKCA, etc.).
- Train teams on regulatory requirements.
Key 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.
Salary (Rate): undetermined
City: Waltham Abbey
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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 13485.
- 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 14971) 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)