Final Reviewer – Certification Decision Maker

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

📋 Description

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

• Make informed decisions regarding the reviewed audit packs to determine the issuance of certificates and any applicable limitations.

• Confirm that the audit documentation for QMS on-site assessments and technical documentation evaluations adheres to regulatory standards.

• Assess whether the final review process has been conducted satisfactorily.

• Inspect audit packs related to QMS on-site audits for MDD / MDR / ISO13485.

• Participate in discussions regarding concessions and certificate suspensions when necessary.

• Collaborate with auditors, product assessors, and the Global Medical Device Certification Manager to achieve operational goals.

⛳️ Requirements

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

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

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

• Excellent communication abilities.

• Strong skills in team building.

• Proficient in English.

• Proficiency in additional languages is an advantage.

🏝️ Benefits

• Flexible working schedule and hybrid work model.

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

• Work in a multinational environment collaborating with colleagues from various continents.

• Benefits platform available.