Clinical Evaluation Specialist

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 collaborate with product, engineering and applied machine learning teams to enhance the tools you use. Your work will turn complex clinical evidence into clear conclusions that support certification decisions, helping safe devices reach patients sooner.

Key responsibilities

• Assess clinical evaluation plans and reports submitted by customers.
• Screen and action regulatory insights from the latest research, standards and guidance.
• Work with product, engineering, design and applied machine learning teams to build and improve systems.
• Collaborate with the 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 profile

• A degree in clinical medicine, nursing, dentistry, epidemiology or public health.
• Minimum of two years’ experience assessing clinical data for medical devices.
• Minimum of two years’ experience in patient care.
• Knowledge of fundamental principles of clinical data assessment for medical devices and medical statistics.
• Practical experience conducting or monitoring clinical investigations or trials, or assessing clinical data.
• Exceptional written and verbal communication skills.

Required skills

• Experience developing, implementing or evaluating medical device software.
• Knowledge of standards such as ISO 14155 and MEDDEV 2-7/1 Rev.4.
• Knowledge of clinical research methodologies and clinical trial design.