Final Reviewer & Certification Decision Maker (Medical Devices)

TL;DR

Final Reviewer & Certification Decision Maker (Medical Devices): Review medical device audit packs to verify compliance with MDD 93/42 EC and MDR (EU) 2017/745 and make certification decisions with an accent on audit documentation quality, unresolved issues, and evidence of compliance. Focus on ensuring QMS and technical documentation assessments meet regulatory and internal procedures before certificates are issued, restricted, suspended, or escalated.

Location: Remote (Europe) — must hold a valid work permit for the country of residency

Company

hirify.global is a global testing, inspection, and certification company focused on sustainability, quality, and integrity.

What you will do

• Review audit packs to verify data and content for compliance with MDD 93/42 EC or MDR (EU) 2017/745 and decide whether a certificate can be issued.
• Check that QMS on-site audit documentation and technical documentation assessments comply with medical device regulations and internal procedures.
• Verify that major nonconformities and any unsolved issues are addressed and closed before transferring the pack for certification decision.
• Confirm that final review was completed by an approved Final Reviewer and that all actions are satisfactorily addressed and closed.
• Review audit packs for QMS on-site audits and technical documentation assessment for MDD/MDR/ISO 13485, including changes, and handle concessions and certificate suspension when relevant.
• Work closely with auditors, product assessors, other certification decision makers, and the Global Medical Device Certification Manager to meet operational objectives and KPIs.

Requirements

• Experience in a similar role in a European notified body (required).
• Significant medical device experience as a Lead Auditor or Product Assessor in a Notified Body (required).
• Detailed understanding of global medical device regulations and strong analytical skills to detect discrepancies.
• Fluent English (required).
• Good communication and strong team-building skills.
• Work permit: must hold a valid work permit for the country of residency and be located in Europe.

Culture & Benefits

• Flexible schedule and hybrid model.
• Global and stable company with a multinational environment across multiple continents.
• hirify.global university and learning options for continuous development.
• Benefits platform.
• Supportive and inclusive work environment focused on innovation, collaboration, and continuous improvement.