Device Specialist

We pull medical technology from the future to solve human health.

Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.

Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.

About the role

As a Device Specialist, you’ll audit management systems and assess technical documentation for medical devices. You’ll use AI-assisted workflows to navigate documentation, interpret requirements, compare evidence and surface gaps for deeper review. You’ll experiment with improvements to your workflows as model capabilities improve and work with our product, engineering and applied machine learning teams to improve the tools you use. Your work will turn complex management-system and technical evidence into rigorous certification decisions that help safe devices reach patients sooner.

Responsibilities

• Audit management systems and assess the technical documentation submitted by our customers

• Work with our product, engineering and applied machine learning teams to build and improve our systems

• Work with our market access team to expand Scarlet's responsibility to new jurisdictions and certifications

Required qualifications

• A bachelor’s degree or higher in engineering, medicine or another relevant science or engineering discipline

• Four or more years’ experience designing, building or researching medical devices

• Two or more years’ experience with quality management systems

• Experience in software design, verification and validation

• Ability to read normative texts and analyse and interpret requirements

• Exceptional written and verbal communication skills

Interview process

1. Intro call with Sandy — 30 mins

2. Team interviews — 2 × 30 mins

3. Technical interview — 1 hour

4. Culture and values interviews with James and Jamie — 2 × 30 mins

5. Referencing and offer