Job Description
Work Flexibility: Remote The Senior Clinical Evaluation Specialist applies scientific, regulatory and project management skills to establish the evaluation strategy and compile a body of clinical evidence, in order to reach a legally binding scientific conclusion on the safety and performance of medical devices throughout the product lifecycle. The Clinical Evaluation Specialist bears the operational responsibility of individual clinical evaluation reports and associated documents. What you will do Support a coherent clinical evidence strategy throughout the new product development cycle, and foster alignment with adjacent complex processes (marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy). Support compliant and sustainable literature search strategies, and perform complex literature queries to retrieve published clinical data, Identify, appraise, and analyze all relevant data (clinical, PMS, marketing, testing, etc.) from multiple sources and formats and create a comprehensive scientific review. Analyze the current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques. Identify unanswered questions and residual risks in the clinical evaluation report, and assist with design of Post Market Clinical Follow Up (PMCF) activities in collaboration with clinical affairs colleagues and/or other subject matter experts to address these questions. Define and develop clinical evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework. What you need Bachelors/Master of Science degree in a health/science-related field. Minimum of 2 years industry experience in clinical, quality or regulatory affairs (risk management, design quality, post-market safety, etc.). Experience in writing clinical evaluations for medical devices required. Strong communication, project management and influencing skills. Must demon
