Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly.
Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.
Come help us bring the next generation of healthcare to the people who need it.
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.
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.
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
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.
Consultant auditor role
Fully remote
Flexible scheduling, subject to audit demand and availability
scarlet