You will critically evaluate clinical evidence for AI-powered medical device submissions seeking EU and UK market access. Using AI-assisted workflows, you’ll assess clinical evaluation reports, review post-market surveillance data, and collaborate with manufacturers. This role bridges the gap between clinical evidence and software-specific risks for the next generation of healthcare technology.
Clinical Evaluation Specialist at Scarlet
Join Scarlet, the only Notified Body in Europe specializing exclusively in AI medical device certification, as they bridge the gap between frontier software and patient safety. As a Clinical Evaluation Specialist in London, you will critically assess the evidence behind groundbreaking products seeking market access in the UK and EU. Backed by Creandum, Scarlet offers a unique opportunity to work at the intersection of clinical expertise and regulatory science, helping innovative AI technologies from companies like Skin Analytics safely reach patients across the globe.
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Location
London, United Kingdom
Compensation
£75k-£90k + 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
- Conduct swift and accurate assessments of clinical evaluation processes and technical documentation for global medical device manufacturers.
- Collaborate with Product, Engineering, and Applied ML teams to build and improve internal AI-assisted regulatory assessment systems.
- Translate complex regulatory topics into actionable content for customers and support Sales functions with deep clinical and regulatory insights.
Who this is a fit for
- Holds a degree in clinical medicine, nursing, or public health, with at least two years of direct experience in patient care.
- Possesses a minimum of two years of professional experience assessing clinical data specifically for medical devices or health-tech software.
- Demonstrates deep knowledge of clinical research methodologies, medical statistics, and relevant regulatory standards such as ISO 14155 or MEDDEV 2-7/1.
Why this role is remarkable
- Join Europe’s only Notified Body dedicated to AI, working at the absolute cutting edge of regulatory science and medical technology.
- Shape the future of healthcare by granting market access to innovative products like Class III AI for skin cancer diagnosis and NHS-deployed AI physiotherapy.
- Work within a high-growth, 65-person startup backed by top-tier investors like Creandum, collaborating directly with AI experts and software engineers.
How Jack & Jill work together
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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.
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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.