Freelance Active Medical Device Auditor- German Speaking

Freelance MDR Auditor – Active Medical Devices (German‑speaking)

Anonymous Notified Body | DACH region

We are supporting a well‑established, EU Notified Body that is currently expanding its external audit capacity due to increased workload and recent changes within its senior audit team.

The organisation is seeking experienced freelance MDR auditors to support active medical device audits in the near and medium term, with the option to transition into a more permanent collaboration if of mutual interest.

Scope of Work

• Conduct MDR 2017/745 audits (certification, surveillance, recertification)
• Focus on active, non‑implantable medical devices
• Typical audits include mixed‑portfolio manufacturers (ISO‑only clients and MDR clients with a wide range of devices)
• Audit locations primarily in:
  • Germany
  • Austria
  • Switzerland
  • with occasional international sites for manufacturers headquartered in the DACH region
• No consultancy activities permitted for audited manufacturers

Key Areas of Interest

Profiles with experience in one or more of the following are particularly welcome:

• Standalone software / software‑driven active devices
• Cybersecurity and AI‑enabled medical devices
• Active non‑implantable respiratory devices (e.g. MDA 0303, 0307, 0315)
• Therapeutic, monitoring, and diagnostic active devices
• Multidisciplinary audits covering several device families within one audit

Requirements

• Proven MDR audit experience within a Notified Body environment
• Background as an auditor and/or technical documentation reviewer
• Broad active device scope (non‑implantable)
• Fluent German (mandatory)
• Good working English
• Based in Germany (or able to reliably travel from Germany)
• Comfortable working as a freelance auditor
• Able to take on anything from 5-10 audits per year up to 30+ audits, depending on availability