Clinical Evaluation Specialist

Role Summary

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.

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

Requirements

• 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

Additional Information

1. Intro call with Kim https://www.linkedin.com/in/kimberly-peven/ — 20 mins
2. Interview with Sandy https: //www.linkedin.com/in/wrightsandy/ — 45 mins
3. Technical interview with Kim https://www.linkedin.com/in/kimberly-peven/ — 1 hour
4. Culture and values interviews with James https://www.linkedin.com/in/james-dewar-78758992 and Jamie https://www.linkedin.com/in/jamie-cox-01458b3a/ — 2 × 30 mins
5. Referencing and offer