Device Specialist (£75k-£85k + Equity) at Scarlet

Job Title

Device Specialist

£75k-£85k + Equity

Scarlet is Europe's only Notified Body specializing exclusively in AI and software medical device certification, authorized by EU and UK governments to grant market access for frontier medical technology.

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.

London, UK

• 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.

• 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.

• 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.