Medical Device Lead Auditor - Freelance

The role

You will independently deliver high-quality QMS audits for medical device companies. You will conduct remote audits under ISO 13485, ISO 27001, ISO 42001, EU MDR, and UK MDR.

What you will do

• Conduct remote audits of medical device manufacturers Quality Management Systems under ISO 13485, ISO 27001, ISO 42001, 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

• A bachelor's degree in software engineering, computer science, physics or biophysics, biology or microbiology, chemistry or biochemistry, electrical, electronic, mechanical engineering or bioengineeri
• Minimum 4 years of experience in the medical device industry
• Minimum 2 years of experience auditing or managing QMSs under ISO 13485, ISO 27001, ISO 42001, 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
• Fulfill the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR and UK MDR

Nice to have

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

Before you apply

• Introductory call with Emily
• Auditor competence & regulatory interviews
• References

About the company

Scarlet is authorised to assess and certify medical devices. They combine clinical, technical and regulatory expertise with AI agents and software.