Lead Auditor

Job Description:
On behalf of our client, we are looking for an experienced and driven Senior Lead Auditor – Active Medical Technologies to join a fast-evolving regulatory assessment team located in the Netherlands. This opportunity is ideal for professionals who are enthusiastic about ensuring device safety and navigating complex regulatory landscapes. You will oversee audits for producers of active devices, ensure adherence to MDR and ISO 13485, and support the growth of junior colleagues and internal initiatives.

Company Description:
Our client is a respected European Notified Body with a strong footprint in the Dutch region. Specializing in active devices, they work extensively with organizations developing software-based and AI-powered health technologies. With a collaborative, development-focused culture and a strong emphasis on employee well-being, the company offers a professional and supportive setting for regulatory professionals seeking long-term growth.

Essential Requirements:

• Substantial auditing experience within a Notified Body, focused on active devices and MDR.

• Strong understanding of ISO 13485 and EU medical technology regulations.

• Background in software and/or artificial intelligence systems in healthcare.

• Fluent in English; Dutch proficiency is an advantage.

• Based in the Netherlands and open to 3–4 audit trips per month.

Additional insights:
The role provides a competitive salary and a robust benefits package. A structured onboarding program and ongoing support from experienced managers will help you succeed. The role combines remote work, on-site audits, and periodic office visits in the wider region.

If you're excited about advancing patient safety and working with cutting-edge technologies in a supportive setting, we welcome your application.