Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly.
Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.
Come help us bring the next generation of healthcare to the people who need it.
About this role:Scarlet’s Devices function is a team of clinicians, AI experts, and software engineers, working together to assess and certify the most innovative and impactful medical device software.
We pride ourselves on delivering fast and efficient assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices.
As we continue to scale our activities and certify more and more medical devices, we need software expertise to provide support across all stages of the customer journey.
You’ll join a team of software experts, conducting swift and accurate device assessments, whilst providing knowledge and expertise to internal functions and external stakeholders.
Your responsibilities:Get authorised to assess the software lifecycle processes of the most innovative medical devices in the world
Collaborate with a multidisciplinary team on technical documentation assessments
Create content to help explain complex regulatory topics to customers and prospects
Screen and action regulatory insights from the latest research, standards and guidance
Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers
Work with our Product, Engineering, Design and Applied ML functions to build and improve our systems
Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies
Education - A degree in computer science or related discipline
Work experience - Minimum of four years experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research
Work experience - Minimum of two years in the design, development or testing of medical device software (or other critical software)
Work experience - Practical experience in conducting performance, verification and validation testing and/ or assessing performance, verification and validation test protocols, data and results for medical device software
Work experience - Practical experience in programming, demonstrating knowledge of one or more programming languages, software testing and debugging techniques
Work experience - Knowledge of the fundamental principles of programming, software development life-cycle processes, software verification and validation testing, software configuration management and problem resolution techniques along with medical device cybersecurity, interaction between medical software and its environment and data protection
Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
Excellent communicator - You have exceptional written & verbal communication skills
Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks
Guidance knowledge - You have knowledge or training in the relevant standards and guidance relevant for medical device software (e.g. IEC 62304, IEC 81001-5-1)
AI fluent - You have strong technical knowledge of modern generative AI (e.g., LLMs, embeddings, RAG, fine-tuning, evaluation/monitoring) and have a rich understanding of how these systems work - and where they fail
Intro chat with Hann - 20 mins
Interview with Sandy and a member of the Devices function - 30 mins each
Technical task & interview with Hann - 1 hour
Culture and values interview with James and Jamie - 30 mins each
Referencing & offer
Top 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
