Job Title
Medical Device Quality Engineer
Salary
£60K––£80K + Equity
Company Description
Scarlet is a Creandum-backed authority on AI medical devices and the only European Notified Body specializing exclusively in AI and software. With a team of ~65 people, Scarlet is authorized by governments to certify the world’s most innovative medical technology, bridging the gap between frontier AI and life‑saving healthcare.
Job Description
As a Medical Device Quality Engineer at Scarlet, you will audit and certify Quality Management Systems for the world’s most ambitious healthtech companies. You’ll decompose complex regulatory requirements like ISO 13485 and EU MDR to design technology‑native certification processes, directly accelerating the safe deployment of medical AI to patients worldwide.
Location
London, UK
Why this role is remarkable
- Join Europe’s only Notified Body dedicated to AI, certifying groundbreaking products from companies like Flok Health and Skin Analytics that traditional legacy bodies struggle to handle.
- Work at a Creandum-backed scale‑up with ~65 employees, proven product‑market fit, and exponentially growing revenue in a critical, high‑barrier‑to‑entry global market.
- Shape the future of healthcare regulation by moving away from legacy “box‑ticking” toward efficient, software‑first audit processes for frontier medical technology and AI applications.
What You Will Do
- Audit and certify the quality management systems (QMS) of innovative healthcare companies building bleeding‑edge medical AI systems and software medical devices.
- Interpret and implement complex regulatory standards, including ISO 13485, EU MDR, and emerging frameworks like the ISO 42001 AI management system standard.
- Design and optimize efficient assessment workflows that allow software medical devices to reach market access in record time without compromising patient safety.
The ideal candidate
- At least 4 years of professional experience in medical devices, including a minimum of 2 years specifically focused on quality management systems like ISO 13485.
- Deep expertise auditing against EU MDR requirements with at least one year of practical experience working with software‑specific standards such as IEC 62304.
- A “ferociously curious” analytical mindset with the ability to interpret normative texts and operate autonomously in a fast‑paced, high‑growth startup environment.
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