Jack & Jill
Medical Device Auditor at Scarlet
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Job Title
Medical Device Auditor
Salary
Not Disclosed
Company Description
Scarlet is a venture-backed London company and Europe's only notified body specializing exclusively in software and AI medical devices. By combining clinical expertise with AI agents, Scarlet enables ambitious healthtech companies to cut certification timelines for life-saving technology from years to months while maintaining rigorous safety standards.
Job Description
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.
Location
London, UK
Why this role is remarkable
- 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.
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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.
The ideal candidate
- 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.
Who are Jack & Jill?
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.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
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.
How does this work?
- 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 it's a match and the company wants to meet you, they'll make the intro. In the meantime, if you'd like, Jack will send you excellent alternatives.
We never post fake jobs
This isn't a trick. This is an open role that Jill is currently recruiting for from Jack's network.
Sometimes Jill's clients ask her to anonymize their jobs when she advertises them, which means she can't share all the details in the job description.
We appreciate this can make them look a bit suspect, but there isn't much we can do about it.
Give Jack a spin! You could land this role. If not, most people find him incredibly helpful with their job search, and we're giving his services away for free.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
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