Certification Decision Maker

Job Summary

To support the Global Medical Device team, the full-time remote Final Reviewer & Certification Decision Maker will review audit packs for compliance with medical device regulations, verify documentation, and make certification decisions based on thorough assessments of quality management systems and technical documentation.

Key responsibilities

• Review audit packs to ensure compliance with MDD 93/42 EC and MDR (EU) 2017/745, and make certification decisions
• Verify that all major non-conformities are addressed and that final review documentation is satisfactorily completed
• 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 and good communication abilities