Lead Auditor - Contractor role

• Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
• Provide clear, structured audit documentation and evidence-based conclusions.
• Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.

Required Qualifications- Bachelor’s degree in:

• software engineering
• computer science
• physics or biophysics
• biology or microbiology
• chemistry or biochemistry
• electrical, electronic, mechanical engineering or bioengineering
• human physiology
• medicine
• pharmacy
• Minimum 4 years of experience in the medical device industry
• Minimum 2 years of experience auditing or managing QMSs under:
• ISO 13485
• EU MDR and/or UK MDR
• Prior work with notified bodies or accreditation bodies as a Lead Auditor
• Working knowledge of relevant standards, such as:
• ISO 14971
• IEC 62304
• IEC 82304
• Cybersecurity
• Evidence of confidently interpreting and applying regulatory requirements.
• Evidence of delivering consistent, high-quality audits.
• Ability to explain findings and requirements clearly and constructively.
• Ability to deliver audits independently with minimal oversight.
• Willingness to adopt Scarlet’s values, audit methods and tooling.

• Practical experience working with software.
• Experience with software medical devices (SaMD).

Interview process

• Introductory call with Emily (30 min)
• Auditor competence & regulatory interviews (2x30-45 min)
• References
• Offer & onboarding