Medical Device Site Auditors & Product Reviewers (EU MDR)

About the role

We are looking for experienced professionals to perform EU MDR site audits and product reviews for a range of medical devices. The role supports regulatory compliance by assessing quality management systems, technical documentation and sterilisation processes.

Key responsibilities

• Conduct QMS audits of manufacturing sites under EU MDR requirements.
• Prepare detailed audit reports and communicate findings to internal decision‑makers.
• Assess technical documentation for active and non‑active medical devices.
• Participate in conformity assessment activities and collaborate with clinical experts.
• Review sterilisation processes (EO, moist heat, radiation, aseptic) and cleanroom compliance where applicable.

Required profile

• At least a B.Sc. in Engineering, Medicine, Pharmacy, Pharmaceuticals or Biochemistry.
• Minimum 4 years of professional experience in the medical‑device sector.
• Relevant MDT, MDA, MDN or MDS code authorisation or eligibility.
• Experience with quality‑management systems and EU MDR conformity assessments.

Required skills

• QMS auditing under EU MDR.
• Technical documentation assessment for medical devices.
• Conformity assessment and regulatory compliance.
• Knowledge of sterilisation methods (EO, moist heat, radiation, aseptic) and cleanroom auditing.