Medical Devices Auditor – Active, High Risk Software

Overview

As a Medical Devices Auditor, you will assess quality management systems to support patient safety and regulatory compliance across the medical device sector. You will travel throughout the EMEA region, gaining expertise in ISO 13485, MDSAP, MDR, and conformity assessments like UKCA and CE marking. You start in training, then conduct audits on-site, remotely, or in hybrid setups, delivering clear reports to clients. This role combines field work with collaboration in a global, standards-driven environment and offers development opportunities in a high-impact area.

Pay / Benefits

• Flexible working hours
• 27 days annual leave
• Health insurance
• Pension plan with company contribution
• Company car
• Paid parental and bereavement leave

Responsibilities

• Attend and complete ISO 13485 Lead Auditor training, MDSAP and MDR courses
• Observe audits initially and progressively conduct audits independently
• Conduct on-site/remote/hybrid audits, solo or with a team
• Write audit reports and coordinate with planning and delivery teams to manage schedules
• Perform administrative tasks as needed

Key requirements

• Minimum 4 years hands-on experience in R&D, design/design development, servicing/maintenance/testing, or manufacturing/production
• At least 2 years experience with quality management systems
• University or technical college degree or equivalent in a related STEM subject (BSc, MSc or PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics

• Adaptability in a changing regulatory landscape
• Strong communication for report writing and client liaison
• Collaborative, team-oriented approach
• ISO 13485
• MDSAP
• MDR

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