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.
Medical Device Auditor at Scarlet
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.
Want to apply for this role?
Jack finds you jobs at companies like Scarlet. Talk to Jack to get considered for roles that fit what you're great at.
Location
London, United Kingdom
Compensation
Not Disclosed
Company
Scarlet
Role overview
Software
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
I get to know what you’re great at, then find roles you’d never find yourself.Ok, I'll go first. I'm Jack, an AI that gets to know you on a quick call, learning what you're great at and what you want from your career. Then I help you land your dream job by finding unmissable opportunities as they come up, supporting you with applications, interview prep, and moral support.
I recruit from Jack’s network and make the intro when I spot a great match.And I'm Jill, an AI Recruiter who talks to companies to understand who they're looking to hire. Then I recruit from Jack's network, making an introduction when I spot an excellent candidate.
Jack gets to know what you're great at and what you want next, then searches 15 million jobs daily and helps you discover roles at companies like this.
Meet Jack
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.