Senior Regulatory Lead, Medical Devices - Radiation Oncology

Siemens Healthineers AG is seeking a Senior Regulatory Affairs Specialist in a hybrid role based in Palo Alto, CA or Austin, TX. You will drive regulatory submissions, guide global strategies for radiation oncology devices, and collaborate across Regulatory Affairs, Product Development, Quality, and Clinical teams to enable timely market access.

The role requires strong regulatory judgment, experience with FDA 510(k), EU MDR, ISO 13485, and related standards, and travel less than 20%.