As a Device Specialist at Scarlet, you will audit management systems and assess technical documentation for the world’s most innovative medical devices. Joining the London-based Assessment team, you will bridge the gap between regulatory standards and cutting-edge technology, helping expand Scarlet’s scope from software into hardware medical device certifications.
Device Specialist at Scarlet
Scarlet is Europe's only Notified Body specializing in AI medical device certification, and they are seeking a Device Specialist to bridge the gap between frontier technology and regulatory approval. This London-based role offers the unique opportunity to audit the world's most innovative medical hardware and software while shaping assessment processes within a high-growth team authorized by governments to bring breakthroughs to patients faster. Joining a mission-driven startup with exponentially growing revenue, you will receive a package of £75K-£85K plus equity while ensuring that life-saving technology from the future reaches the people who need it today.
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Location
London, United Kingdom
Compensation
£75k-£85k + 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 rigorous technical assessments of documentation and audit quality management systems for innovative medical devices to ensure regulatory compliance.
- Collaborate with internal software engineers and clinicians to design and optimize world-class tooling and processes for medical device conformity assessments.
- Stay at the forefront of international standards and regulatory guidance, incorporating new requirements into Scarlet’s expanding global approval frameworks.
Who this is a fit for
- Holds a Bachelor’s degree or higher in engineering, medicine, or a relevant scientific discipline with a deep understanding of technical requirements.
- Possesses at least four years of professional experience in medical device manufacturing or research, including two years specifically in design and testing.
- Brings two years of dedicated experience in quality management systems and a proven ability to interpret complex normative texts and regulatory standards.
Why this role is remarkable
- Join Europe’s only Notified Body dedicated to AI and software medical devices, working at the intersection of regulatory law and frontier health technology.
- Participate in a high-growth environment with exponentially growing revenue and a proven product-market fit that is now scaling into hardware devices.
- Shape the future of medical device approvals globally, directly reducing delays so life-saving technology reaches patients significantly faster.
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