Senior Regulatory Affairs Specialist Siemens Healthineers

Siemens Healthineers is seeking a Senior Regulatory Affairs Specialist, who will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required. Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams. Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS). Collaborate with cross‑functional teams to develop and maintain quality guidelines, procedures, and work instructions that support ongoing regulatory compliance. Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy. Provide training to internal stakeholders on country‑specific regulatory requirements, as applicable. Independently or as part of a team, review promotional and labeling materials for regulatory compliance in accordance with country‑specific requirements. Ensure audit‑and inspection‑ready documentation and provide guidance to cross‑functional teams on appropriate regulatory documentation practices. Participate in internal and external audits, including quality system audits, design dossier reviews, and regulatory authority inspections, as applicable. #J-18808-Ljbffr G-MedTech