Senior Regulatory Affairs Program Lead (Software/OTTAVA)

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Program Lead (Software/OTTAVA) based in the United States . This senior regulatory affairs role will help drive US and international regulatory approval strategies for an advanced surgical robotics portfolio. You will lead regulatory planning and execution throughout the product lifecycle, from development and submission through approval and post-market activities. Working closely with engineering, clinical, and cross-functional teams, you will ensure that product documentation and development activities meet applicable regulatory requirements. You will provide strategic guidance on software-enabled electromechanical medical devices, including robotics systems and connected technologies. The position also involves preparing and authoring FDA submissions, supporting health authority interactions, and navigating evolving regulatory standards. This is an opportunity to contribute to innovative surgical technologies while helping expand patient access to advanced medical solutions.