Lead Auditor – Medical Device (Contractor)

About the role

This contractor position is based in Switzerland and focuses on independent audits of Quality Management Systems for medical device manufacturers. You will work remotely, applying your expertise in ISO 13485, EU MDR and UK MDR to ensure compliance with the highest regulatory standards.

Key responsibilities

• Conduct remote audits of medical device manufacturers’ QMS in line with ISO 13485, EU MDR and UK MDR.
• Review objective evidence, identify findings and produce clear, structured audit reports.
• Maintain audit methodology, quality expectations and regulatory principles throughout each engagement.
• Provide consistent, professional audit experiences and support continuous improvement of audit processes.
• Apply sound regulatory judgement when interpreting requirements and evaluating compliance.

Required profile

• Bachelor’s degree in a scientific or engineering discipline (e.g., engineering, biology, chemistry, medicine).
• Minimum 4 years of experience in the medical device industry.
• At least 2 years auditing or managing QMS according to ISO 13485 and EU/UK MDR.
• Previous experience as a Lead Auditor for notified or accreditation bodies.
• Strong understanding of medical device regulations, quality systems and relevant standards.

Required skills

• ISO 13485
• EU MDR
• UK MDR
• ISO 14971
• IEC 62304
• IEC 82304
• Medical device cybersecurity requirements
• Software as a Medical Device (SaMD) auditing

What we offer

• Flexible contractor model with fully remote audit assignments.
• Opportunity to contribute to faster access to safe and effective health innovations.
• Collaboration within a quality‑focused, high‑impact health‑tech ecosystem.