Senior Regulatory Affairs Expert - Medical Devices & IVDs

Siemens Healthineers AG in the United States is seeking a Regulatory Affairs expert to prepare and manage regulatory submissions, including FDA 510(k) and IVDR/File lifecycle documentation. You will guide product development teams on regulatory strategy and ensure QMS alignment across functions. The role emphasizes cross‐functional collaboration, meticulous attention to detail, and strong knowledge of GMP standards. Prior experience with medical devices and IVDs is highly valued.