Final Reviewer – Certification Decision Maker

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

📋 Description

• Examine audit packs to ensure data and their contents comply with MDD 93/42 EC or MDR (EU) 2017/745 standards.

• Confirm that the audit documentation for QMS on-site, as well as the technical documentation assessment, aligns with medical device regulations.

• Ensure that any major non-conformities and unresolved issues are addressed prior to forwarding the audit pack for certification decisions.

• Assess whether the final review has been performed by an authorized Final Reviewer.

• Make the ultimate determination on the issuance of a certificate.

• Inspect audit packs for QMS on-site audits in accordance with MDD / MDR / ISO13485 standards.

• Contribute to the achievement of operations objectives and Key Performance Indicators to provide certificates to clients.

⛳️ Requirements

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

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

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

• Excellent communication abilities.

• Strong skills in team building.

• Proficiency in English.

• Additional language skills are advantageous.

🏝️ Benefits

• Flexible working hours and a hybrid work model.

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

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

• Access to a comprehensive benefits platform.