Final Reviewer, Certification Decision Maker

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

📋 Description

• Examine audit packages to confirm data accuracy and adherence to MDD 93/42 EC or MDR (EU) 2017/745.

• Make determinations regarding the issuance of certificates based on the reviewed audit packages.

• Ensure compliance with medical device regulations and internal policies.

• Review audit packages in preparation for QMS on-site audits for MDD / MDR / ISO13485.

• Work collaboratively with auditors and medical device certification teams.

⛳️ Requirements

• Proven experience in a comparable 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).

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

• Proficient in English; additional languages 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.