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

Intro call with Sandy — 30 mins

Team interviews — 2 × 30 mins

Technical interview — 1 hour

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

Referencing and offer