Lead Auditor - Contractor role

Job description

We pull medical technology from the future to solve human health. Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar. Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale. 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