Clinical Evaluation Specialist

Job description

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 THIS ROLE: Scarlet’s Devices function is a team of clinicians, AI experts, and software engineers, working together to assess and certify the most innovative and impactful medical device software. We pride ourselves on delivering fast and efficient assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices. As we continue to scale our activities and certify more and more medical devices, we need clinical and regulatory expertise to provide support across all stages of the customer journey. You’ll join a team of clinical evaluation experts, conducting swift and accurate device assessments, whilst providing knowledge and expertise to internal functions and external stakeholders. YOUR RESPONSIBILITIES: - Get authorised to assess the clinical evaluation processes of the most innovative medical devices in the world - Collaborate with a multidisciplinary team on technical documentation assessments - Create content to help explain complex regulatory topics to customers and prospects - Screen and action regulatory insights from the latest research, standards and guidance - Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers - Work with our Product, Engineering, Design and Applied ML functions to build and improve our systems - Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies THE KEY SKILLS: - Education - A degree in clinical medicine, nursing, dentistry, epidemiology or public health - Work experience - Minimum of two years experience with the assessment of clinical data for medical devices - Work experience - Experience developing, implementing or evaluating medical device software - Work experience - Knowledge of the fundamental principles of the assessment of clinical data for medical devices and medical statistics - Work experience - Minimum of two years experience in patient care - Work experience - Practical experience in conducting or monitoring clinical investigations/trials or assessing clinical data DESIRABLE SKILLS: - Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo - Excellent communicator - You have exceptional written & verbal communication skills - Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks - Guidance knowledge - You have knowledge or training in the relevant standards and guidance used for clinical evaluation (e.g. ISO 14155, MEDDEV 2-7/1 Rev.4) - Research savvy - You have knowledge of different clinical research methodologies, including experience designing or contributing to the development of clinical trials THE INTERVIEW PROCESS 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 interview with James https://www.linkedin.com/in/james-dewar-78758992 and Jamie https://www.linkedin.com/in/jamie-cox-01458b3a/ - 2x30 mins 5. Referencing & offer