Medical Device Auditor at Scarlet
- Location
- London, United Kingdom
- Compensation
- Not Disclosed
Scarlet is Europe's only notified body specializing exclusively in software and AI medical devices, and they are looking for a Medical Device Auditor to join their venture-backed team in London.
This isn't a traditional auditing role; you'll be working at the intersection of regulatory rigor and frontier AI, helping the world's most ambitious healthtech companies cut certification timelines from years to months.
If you have deep ISO 13485 experience and a passion for how software is transforming medicine, this is your chance to shape how life-saving technology reaches patients. Enjoy a hybrid London environment, visa sponsorship, and a modern approach to auditing that prioritizes impact over paperwork.
What's the next step?
Scarlet are hiring from Jack's network. Talk to Jack for free and get a direct introduction to the team, if a good fit.
Role overview
As a Medical Device Auditor at Scarlet, you will assess manufacturers’ quality management systems against ISO 13485, EU MDR, and UK MDR standards. You’ll work directly with teams building frontier medical AI, ensuring safe devices reach patients faster. This role combines technical evidence review with constructive dialogue, supported by Scarlet’s modern, software-driven audit tools.
About Scarlet
Software · 100 employees
Scarlet certifies AI products on behalf of governments.
Today, Scarlet specialises in the certification of software and AI as medical devices (SaMD and AIaMD). As the only Notified Body in Europe specialising exclusively in certifying software and AI, Scarlet accelerates the transition to universally accessible healthcare by enabling manufacturers to certify their medical devices efficiently and make frequent software releases. Scarlet provides dual UK and EU market access.
What you will do
- Plan and conduct comprehensive QMS audits against ISO 13485, EU MDR, and UK MDR requirements for leading healthtech manufacturers.
- Review technical records and interview engineering teams to assess how their software development processes align with safety and regulatory standards.
- Document evidence and findings in clear audit reports, providing constructive feedback and reviewing corrective actions to support final certification decisions.
Who this is a fit for
- Holds a degree in a scientific, engineering, or medical discipline and has at least four years of experience within the medical device industry.
- Possesses at least two years of experience auditing or managing an ISO 13485 QMS with working knowledge of EU/UK MDR requirements.
- Demonstrates a strong understanding of software lifecycle processes, including design, validation, and testing, and can communicate complex findings clearly to technical teams.
Why this role is remarkable
- You will join Europe’s only notified body dedicated to AI and software, positioning yourself at the absolute frontier of medical technology regulation.
- Work at a fast-growing, venture-backed scale-up where your audit judgment directly accelerates the delivery of life-saving AI innovations to the healthcare market.
- Benefit from a modern audit environment with limited travel, hybrid flexibility, and specialized training in regulatory methods designed specifically for the software age.
How Jack & Jill work together
What happens next?
Jack’s an AI agent for job searching and career coaching. He works for you.
Jill is the AI recruiter working for the company. She recruits from Jack’s network.
If your profile’s a match and Scarlet wants to meet, Jill will make the intro. In the meantime, Jack will send you excellent alternatives.