Medical Device Certification Reviewer

Job Summary

Working remotely, the full-time Final Reviewer & Certification Decision Maker will review audit packs for compliance with medical device regulations, make certification decisions, and ensure all documentation meets required standards.

Key responsibilities

• Review audit documentation to verify compliance with MDD 93/42 EC or MDR (EU) 2017/745 and determine certification issuance
• Ensure all major non-conformities are addressed before transferring audit packs for certification decisions
• Collaborate with auditors and product assessors to meet operational objectives and maintain regulatory compliance

Required qualifications

• Experience in a similar position within a European notified body
• Significant work experience in the medical device field as a Lead Auditor or Product Assessor
• Detailed understanding of global medical device regulations
• Fluent in English; additional languages are a benefit
• Strong team building skills