The role
* Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling * Ensure compliance with regulatory standards and testing requirements throughout product design and development * Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities * Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions * Coordinate regulatory product strategies * Lead regulatory aspects of product and process changes, including regulatory documentation.