You will audit and certify Quality Management Systems for the world’s most innovative medical AI companies. By decomposing complex regulatory requirements like ISO 13485 and EU MDR into efficient, tech-native audit processes, you will directly accelerate the delivery of life-saving software to patients while shaping the frontier of healthcare certification.
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Medical Device Quality Engineer at Scarlet
Are you a Quality Engineer tired of legacy bureaucracy? Join Europe's only Notified Body dedicated to AI and software medical devices. Backed by Creandum and seeing exponential revenue growth, this team is rewriting the rules for how frontier healthtech reaches patients. You'll audit the world's most innovative AI manufacturers and build tech-native certification processes that keep pace with software innovation. If you have 4+ years of medical device experience and a passion for ISO 13485 and IEC 62304, this is your chance to lead the transition to universally accessible healthcare from a position of real authority.
About this role
Role overview
About the company
Scarlet
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'll do
What you will do
- Get authorized to audit and certify the Quality Management Systems of leading healthcare innovators against ISO 13485 and EU MDR standards.
- Decompose and implement technical requirements for medical device software, including IEC 62304, cybersecurity, and AI-specific frameworks like ISO 42001.
- Optimize the assessment of customer data by designing efficient audit workflows that enable rapid and secure market access for global manufacturers.
Who you are
Who this is a fit for
- Has at least four years of professional experience in medical devices, with a minimum of two years focused on quality management and auditing.
- Possesses technical expertise in medical device software requirements (IEC 62304/82304) and practical knowledge of software development methodologies.
- Is a ferociously curious analytical reader who thrives on understanding deep technical systems and challenging the regulatory status quo in an autonomous environment.
Why this role
Why this role is remarkable
- Join the only authorized body in Europe exclusively focused on AI and software medical devices, working with the world’s most ambitious healthtech companies.
- Benefit from a high-growth environment with exponentially growing revenue, product-market fit, and backing from top-tier investors like Creandum.
- Move beyond traditional "box-ticking" to design technology-native certification processes for software that updates weekly, fundamentally changing how medical AI reaches the market.
Jack & Jill
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.
Meet Jack
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.
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.