We pull medical technology from the future to solve human health.
Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.
About this role:
Scarlet’s Devices function is a team of clinicians, software engineers and device specialists, working together to audit, assess and certify the most innovative and impactful medical devices.
We pride ourselves on delivering efficient audits and fast technical assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices.
We are both the designers and operators of our auditing and assessment processes, working with Scarlet's internal team of software developers, product designers, and ML engineers, to develop world-class tooling to support conformity assessment.
We’ve proven our capabilities with medical device software and are actively expanding our scope to include hardware medical devices.
Your responsibilities:
Get authorised to audit management systems and assess the technical documentation of the most innovative devices in the world.
Collaborate with product, engineering, and ML to optimise our processes and continue to scale them.
Collaborate with teammates in the operations function to expand the scope of Scarlet’s approvals to enable our customers to reach more people.
Key skills:
You've got a bachelor’s degree or higher in engineering, medicine or other relevant science or engineering discipline
You've worked for 4+ years designing, building and/or researching medical devices
You've got 2+ years of experience with quality management systems
You have experience in software design, verification and validation
You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information
You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks
You have exceptional written & verbal communication skills
The interview process:
Intro call with Sandy - 30 mins
Team interviews - 2 x 30 mins
Technical interview - 1 hour
Culture and values interview with James and Jamie - 2 x 30 mins
Referencing & offer
Skills Required
- Bachelor's degree or higher in engineering, medicine, or relevant science/engineering discipline
- Minimum four years professional experience in manufacturing, auditing, or research of medical devices
- Minimum two years professional experience in design, manufacture, or testing of medical devices
- Two years professional experience in quality management
- Analytical reader (ability to interpret normative texts and extract requirements)
- Ferociously curious (deep technical curiosity and investigative mindset)
- Highly adaptable (ability to operate autonomously in ambiguous environments)
- Excellent written and verbal communication skills
What We Do
Scarlet certifies software medical devices. We are Europe’s only Notified Body specialised in Software & AI. Our mission is to hasten the transition to accessible, affordable healthcare. We strive to achieve our mission by enabling our customers to deliver on theirs, and get their life-changing technology to the people who need it. Scarlet was built specifically for software and AI medical devices. We help customers to get their SaMD certified in the EU & UK, and ship the kind of regular updates inherent to good software, ensuring patients can safely get the most up-to-date technology. Scarlet is designated as an EU Notified Body under regulation (EU) 2017/745 (EU MDR). And a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended). Scarlet is also accredited to issue ISO 13485 certificates
