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Siemens Healthineers AG

Senior Regulatory Strategy Lead — Medical Devices

northern, KY

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Job description

Siemens Healthineers AG seeks a Senior Regulatory Affairs Specialist to lead complex regulatory submissions for radiation oncology products. You will guide cross-functional teams, assess regulatory risks, and advise leadership on compliant strategic options for global market access.

Ideal candidates bring experience with FDA/Health Canada/EU MDR and excellent regulatory writing skills, with the ability to translate technical data into actionable regulatory positions across fast-paced programs.

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