Isabelle Puraye

Isabelle Puraye is a skilled professional in regulatory affairs, clinical affairs, and quality assurance, currently serving as a Regulatory Affairs / Clinical Affairs / Quality Assurance Specialist at DentalMonitoring since August 2019. In this role, Isabelle managed FDA registration projects, authored a De Novo Classification Request for the first AI/ML-enabled Software as a Medical Device in dentistry, and developed various regulatory strategies and clinical investigation programs. Prior experience includes working as a Regulatory Affairs Specialist at Stago, where Isabelle prepared 510(k) submissions and collaborated with FDA reviewers, and as a Clinical Affairs & Regulatory Affairs Intern, focusing on study management and analysis. Isabelle holds a Master's degree in Health Biotechnology from ONIRIS - Ecole Nationale Vétérinaire, Agroalimentaire et de l'Alimentation.