Auditor/Product Reviewer- Active Devices EU (MDR) 2017/745

Overview

We are seeking experienced freelance Auditors and Technical Documentation Reviewers specialising in Active Medical Devices to support ongoing projects with leading European Notified Bodies under the EU MDR. This work involves a combination of QMS audits, MDR conformity assessments, and in‑depth technical documentation reviews across a wide range of electromechanical and software‑based medical technologies.

This opportunity is ideal for professionals with strong regulatory expertise, deep technical understanding, and the flexibility to support Notified Body workloads on a freelance basis.

Key Responsibilities

• Conduct ISO 13485 audits (Stage 1, Stage 2, Surveillance, and Unannounced) for manufacturers of Active Medical Devices.

• Perform MDR 2017/745 conformity assessments in accordance with relevant Annexes.

• Review Technical Documentation for Active Devices, including electrical safety, EMC, software, usability, and clinical evaluation components.

• Assess risk management files in line with ISO 14971.

• Evaluate software lifecycle documentation in accordance with IEC 62304.

• Review electrical safety and performance documentation under the IEC 60601 series.

• Provide clear, structured audit reports and technical assessments.

• Collaborate with Notified Body teams to support designation‑specific activities.

• Ensure all assessments meet MDR, harmonised standards, and NB procedural requirements.

Essential Requirements

• Notified Body experience is essential – either as an Auditor, Technical Reviewer, Product Assessor, or similar designation.

• Strong knowledge of MDR 2017/745 and its application to Active Medical Devices.

• Proven experience conducting ISO 13485 audits.

• Demonstrated ability to review Technical Documentation for Active Devices.

• Solid understanding of key standards, including:

  • ISO 13485

  • ISO 14971

  • IEC 60601 series

  • IEC 62304

  • IEC 62366

• Experience assessing clinical evaluation documentation (MEDDEV 2.7/1 Rev. 4, MDR Annex XIV).

• Background in engineering or a related scientific discipline (e.g., biomedical, electrical, mechanical, software).

• Strong analytical, reporting, and communication skills.

• Ability to work independently and manage deadlines.

• Fluency in English; additional European languages are an advantage.

Preferred Experience

• Prior designation in NB codes related to Active Devices (e.g., MD 0107, MD 0108, MD 0111, etc.).

• Experience with SaMD, digital health technologies, or AI‑based medical devices.

• Familiarity with cybersecurity requirements for medical devices.

• Experience with PMS, PMCF, and clinical investigation documentation.

• Understanding of international regulatory frameworks (FDA, UKCA, etc.).

Engagement Details

• Freelance, remote‑based collaboration.

• Flexible workload depending on NB needs and your availability.

• Long‑term opportunities for ongoing audit and technical review assignments.

• Competitive daily rates aligned with NB‑level expertise.