Regulatory Strategy Lead for Robotic Surgery

Surgitec Robotics is seeking a Regulatory Affairs Specialist to translate EU MDR 2017/745 and FDA 510(k) requirements into actionable steps. You will collaborate with R&D, QA, and leadership to build a robust regulatory strategy and documentation for a robotic surgery platform.

The role covers design reviews, device classifications, and regulatory registrations, with emphasis on accelerating compliant pathways and CE/FDA submissions in a startup environment.