As a Medical Device Quality Engineer at Scarlet, you will audit and certify Quality Management Systems for the world’s most ambitious healthtech companies. You’ll decompose complex regulatory requirements like ISO 13485 and EU MDR to design technology-native certification processes, directly accelerating the safe deployment of medical AI to patients worldwide.
Medical Device Quality Engineer at Scarlet
Join Scarlet, Europe’s only Notified Body specializing exclusively in AI and software medical devices. Backed by Creandum and growing exponentially, Scarlet is authorized by governments to certify the world’s most ambitious healthcare technology. As a Medical Device Quality Engineer, you’ll move beyond traditional "box-ticking" to audit frontier medical AI systems, helping life-saving technology reach patients faster. This is a rare opportunity to shape the regulatory landscape for the next generation of healthcare while working in a high-impact, software-native environment alongside regulatory experts and software safety engineers.
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Location
London, United Kingdom
Compensation
£60k--£80k + Equity
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
- Audit and certify the quality management systems (QMS) of innovative healthcare companies building bleeding-edge medical AI systems and software medical devices.
- Interpret and implement complex regulatory standards, including ISO 13485, EU MDR, and emerging frameworks like the ISO 42001 AI management system standard.
- Design and optimize efficient assessment workflows that allow software medical devices to reach market access in record time without compromising patient safety.
Who this is a fit for
- At least 4 years of professional experience in medical devices, including a minimum of 2 years specifically focused on quality management systems like ISO 13485.
- Deep expertise auditing against EU MDR requirements with at least one year of practical experience working with software-specific standards such as IEC 62304.
- A “ferociously curious” analytical mindset with the ability to interpret normative texts and operate autonomously in a fast-paced, high-growth startup environment.
Why this role is remarkable
- Join Europe’s only Notified Body dedicated to AI, certifying groundbreaking products from companies like Flok Health and Skin Analytics that traditional legacy bodies struggle to handle.
- Work at a Creandum-backed scale-up with ~65 employees, proven product-market fit, and exponentially growing revenue in a critical, high-barrier-to-entry global market.
- Shape the future of healthcare regulation by moving away from legacy “box-ticking” toward efficient, software-first audit processes for frontier medical technology and AI applications.
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.