Scarlet
Medical Device Auditor
- Location
- London, Greater London, GB
- Arrangement
- On-site
- Employment type
- Full-time
- Posted
- 9 September 2026 (21 days ago)
Checked 8 days agoApplications go to the employer, never to RoleSprint
About this role
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
As a Medical Device Auditor at Scarlet, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in Scarlet’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.
RESPONSIBILITIES
- Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements.
- Review records and interview teams to assess whether their processes meet the requirements.
- Document evidence, findings and conclusions in clear, timely audit reports.
- Explain findings constructively and keep customers informed throughout the audit.
- Review corrective actions and the evidence needed to close findings.
REQUIRED QUALIFICATIONS
- A degree in a relevant scientific, engineering or medical discipline.
- At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.
- Working knowledge of EU MDR or UK MDR requirements for quality management systems.
- Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation.
- Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment.
PREFERRED QUALIFICATIONS
- Experience conducting audits for a certification or notified body.
- Experience with medical device software.
INTERVIEW PROCESS
1. Introductory call with Sandy https://www.linkedin.com/in/wrightsandy/ — 30 minutes.
2. QMS audit exercise and discussion with Felicia https://se.linkedin.com/in/felicia-aldrin — 60 minutes.
3. Culture and values interviews with James https://www.linkedin.com/in/james-dewar-78758992/ and Jamie https://www.linkedin.com/in/jamie-cox-01458b3a/ — 30 minutes each.
4. References and offer.
Locations
- London, Greater London, GB
- Stockholm, SE
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About this listing
Published on Ashby under the board identifier Scarlet, which is the name the employer’s own job board carries. RoleSprint has not verified the company’s registered or trading name, so it is shown exactly as published rather than tidied up.
RoleSprint is not the employer and not a recruiter. Applications are made on the employer’s own site and never reach us; what RoleSprint does is help you decide whether a role is worth your time and prepare for it if it is.
Published 9 September 2026, last checked 8 days ago. A posting stops being advertised here 90 days after the employer published it, and one the employer takes down is marked closed rather than quietly removed.