Join Scarlet as our first Active Device Specialist to spearhead our expansion from AI software into hardware medical devices. You will design and implement the regulatory processes for assessing cutting-edge active devices, ensuring they meet rigorous international standards. This is a foundational role shaping the future of global healthcare technology certification.
Active Device Specialist at Scarlet
Join Scarlet as the first Active Device Specialist and help redefine how medical hardware reaches the market. Backed by Creandum and led by an expert team of clinicians and engineers, Scarlet is the pre-eminent authority on AI medical devices. You’ll have the unique opportunity to build our hardware assessment function from scratch, leveraging your expertise in IEC 60601-1 to certify the next generation of life-saving technology. With a London-based team, £75k-£85k salary, and meaningful equity, this is a rare chance to take a leadership role in a high-growth company that is accelerating the transition to universally accessible healthcare.
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Location
London, United Kingdom
Compensation
£75k-£85k + Equity
Company
Scarlet
Role overview
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
- Develop and lead Scarlet’s internal processes for assessing active hardware medical devices, ensuring compliance with the IEC 60601-1 family of standards.
- Act as the primary technical authority for hardware assessments, defending Scarlet's methodologies to external experts and government regulators.
- Evaluate technical documentation for innovative active devices, designing efficient data-assessment workflows that maintain the highest safety and quality benchmarks.
Who this is a fit for
- Holds a Bachelor’s degree or higher in Biomedical, Electrical, or Mechanical Engineering with deep technical expertise in active hardware.
- Brings at least four years of professional experience in the design, manufacturing, or auditing of active medical devices under international regulatory frameworks.
- Possesses hands-on experience implementing IEC 60601-1 standards and a strong analytical ability to interpret complex normative requirements for innovative technology.
Why this role is remarkable
- Be the founding specialist for Scarlet's hardware division, transitioning a proven software-certification model into the complex world of active medical devices.
- Work at the forefront of healthcare innovation with a high-growth startup backed by top-tier investors like Creandum and led by experienced founders.
- Directly impact patient safety and accessibility by streamlining the market entry for the world's most advanced medical hardware and AI integrations.
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