Siemens Healthineers
Knoxville, TN
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. Analyzes the requirements and prepares product related regulatory submissions. Collection, preparation and assembly of documentation required for various submissions to the US FDA that include but not limited to the following: Promotional materials, ANDA supplements, Annual Reports, Field Alert Reports, Adverse Event Reporting, Information Requests, external audit responses, etc. Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals. Process product complaints, including conducting the...