Final Reviewer – Certification Decision Maker

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

📋 Description

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

• Assess whether the certificate can be granted and identify any applicable restrictions.

• Confirm that the audit documentation for QMS on-site and technical documentation evaluation adheres to medical device regulations.

• Ensure that all significant non-conformities and unresolved issues have been addressed and resolved.

• Evaluate if the final review has been completed by an authorized Final Reviewer.

• Maintain full adherence to the Company’s Code of Integrity & Professional Conduct.

• Report on your daily workload and any technical issues encountered.

⛳️ Requirements

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

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

• Comprehensive understanding 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.

• Knowledge of additional languages is advantageous.

🏝️ Benefits

• Flexible work schedule and hybrid working model.

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

• Work in a multinational environment alongside colleagues from various continents.