Lead Auditor & Technical Assessor

Job Title: Active Medical Device Lead Auditor and Technical Expert

Company: Medical Device Notified Body

POSITION OVERVIEW

We are seeking an experienced Active Medical Device Lead Auditor and Technical Expert to join our conformity assessment team. In this role, you will play a critical part in evaluating the safety, performance, and regulatory compliance of active medical devices from manufacturers worldwide.

KEY RESPONSIBILITIES

• Conduct comprehensive reviews of technical documentation for assigned active medical devices, assessing compliance with Regulation (EU) 2017/745 (Medical Device Regulation - MDR)
• Evaluate Quality Management Systems (QMS) against ISO 13485 requirements to ensure conformity and continuous improvement
• Lead and perform audits of medical device manufacturers, including on-site assessments and remote evaluations
• Manage certification activities for an international portfo...