JENAVALVE TECHNOLOGY INC

Responsible for the preparation and submission of global regulatory documentation for medical devices, including clinical and post-market applications. Collaborates with cross-functional teams to ensure regulatory strategy alignment and manages ongoing compliance with regulatory bodies and standards.

Lead and develop a clinical data management team while building the function's infrastructure from the ground up. Oversee end-to-end data management for active trials, ensuring data integrity and submission readiness in partnership with Clinical Operations and Biostatistics.