Clinical Evaluation 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 Clinical Evaluation Specialist, you’ll assess clinical evidence, interpret research and regulatory guidance. You’ll use AI-assisted workflows to navigate evidence, compare claims and surface questions 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 clinical evidence into clear conclusions that support certification decisions that help safe devices reach patients sooner.

Responsibilities

Assess clinical evaluation plans and reports submitted by our customers

Screen and action regulatory insights from the latest research, standards and guidance

Work with our product, engineering, design 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

Create content to explain complex regulatory topics to customers and prospects

Provide regulatory insights to prospects and customers

Required qualifications

A degree in clinical medicine, nursing, dentistry, epidemiology or public health

Minimum of two years’ experience with the assessment of clinical data for medical devices

Minimum of two years’ experience in patient care

Knowledge of the fundamental principles of the assessment of clinical data for medical devices and medical statistics

Practical experience in conducting or monitoring clinical investigations or trials, or assessing clinical data

Exceptional written and verbal communication skills

Preferred qualifications

Experience developing, implementing or evaluating medical device software

Knowledge or training in the relevant standards and guidance used for clinical evaluation, such as ISO 14155 and MEDDEV 2-7/1 Rev.4

Knowledge of different clinical research methodologies, including experience designing or contributing to the development of clinical trials

Interview process

Intro call with Kim — 20 mins

Interview with Sandy — 45 mins

Technical interview with Kim — 1 hour

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

Referencing and offer