Clinical Development Manager with a proven track record in managing global MedTech and SaMD trials, ensuring compliance with FDA and EU MDR regulations, and leading cross-functional teams to success.
Expert in clinical trial management, regulatory submissions, and budget oversight, with a focus on AI-based diagnostics and Class III medical devices, delivering high-quality outcomes across multiple geographies.
Skilled in developing and executing clinical protocols, managing vendor relationships, and ensuring audit readiness, with extensive experience in NHS, academic, and digital health collaborations.
Adept at authoring regulatory documents, conducting systematic literature reviews, and maintaining PMS/PMCF strategies to ensure ongoing device safety and performance tracking.