Siemens Healthineers
Walpole, NH
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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,...