Lead Auditor, Scarlet

• A bachelor’s degree in either:
• 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

Desirable

• As a Lead Auditor - Contractor at Scarlet, you will independently deliver efficient, high-quality QMS audits that help innovative medical device companies meet the highest regulatory standards
• We’re expanding our auditor pool, and we're looking for part-time/contractor lead auditors who can independently deliver audits in line with Scarlet’s standards, approach and culture
• This role is suited for auditors who fulfil the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR and UK MDR. You will work flexibly, supporting audit delivery as part of Scarlet’s notified body activities. This is a fully remote role, with flexible scheduling, subject to audit demand and availability
• 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

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