Final Reviewer – Certification Decision Maker

This is a fully remote position, open to applicants in Italy.

📋 Description

• Assess audit packs to confirm data accuracy and compliance with MDD 93/42 EC or MDR (EU) 2017/745.

• Make determinations on audited packs to decide if certification should be granted.

• Ensure that audit documentation for QMS and technical evaluations adhere to medical device regulations.

• Confirm that all significant non-conformities and unresolved issues have been adequately addressed.

• Evaluate whether the final review has been conducted by an authorized Final Reviewer.

• Ensure SGS functions in alignment with professional, ethical, legal, and accreditation standards to retain all certifications.

• Report on your daily tasks and any technical challenges encountered.

⛳️ Requirements

• Proven experience in a comparable role within a European notified body (mandatory).

• Extensive experience in the medical device sector as a Lead Auditor or Product Assessor in a Notified Body (mandatory).

• In-depth knowledge of global medical device regulations and strong analytical skills to identify discrepancies or issues.

• Excellent communication abilities.

• Strong skills in team building.

• Proficient in English.

• Proficiency in additional languages is advantageous.

🏝️ Benefits

• Flexible work schedule and hybrid work model.

• Access to SGS university and Campus for ongoing learning opportunities.

• Benefits platform.