Lead Auditor - Contractor role

We pull medical technology from the future to solve human health.   Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue. ABOUT THE ROLE Scarlet’s Quality Team ensures that innovative medical device companies meet the highest regulatory standards. We support cutting-edge healthtech through efficient, high-quality QMS audits. We’re expanding our auditor pool and are 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. YOUR RESPONSIBILITIES - 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 & EXPERIENCE - Education - 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 - Professional experience - 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 - Preferred: Practical experience working with software. - Auditing experience - Prior work with notified bodies or accreditation bodies as a Lead Auditor - Technical experience - Experience with software medical devices (SaMD) is strongly preferred - Working knowledge of relevant standards, such as: - ISO 14971 - IEC 62304 - IEC 82304 - Cybersecurity WHAT WE’RE LOOKING FOR - Strong regulatory judgement — you are confident in interpreting and applying regulatory requirements. - Consistency & quality focus — you care deeply about audit quality and repeatability. - Clear communicator — you explain findings and requirements clearly and constructively. - Independent & reliable — you can deliver audits with minimal oversight - Aligned mindset — you are open to adopting Scarlet’s values, audit methods and tooling. ENGAGEMENT MODEL - Consultant auditor role - Fully remote - Flexible scheduling, subject to audit demand and availability INTERVIEW PROCESS - Introductory call with Emily https://www.linkedin.com/in/emilyotterbeck/ (45 min) - Auditor competence & regulatory interview with a Scarlet auditor (45 min) - Case study with Johan https://www.linkedin.com/in/johan-julin/ - Complete a case study (maximum 60 min) - Present the case study (30 min) - References - Offer & onboarding