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Senior Submissions Coordinator
Durham, NC, USPosted 1 weeks ago
remote
Job Description
This position is intended to provide technical documentation and Submissions expertise and support to all FUJIFILM Healthcare Americas Corporation (HCUS) business sites. A Submissions Coordinator plays a crucial role in ensuring that products meet regulatory standards and facilitates the submission process to regulatory agencies such as but not limited to U.S. Food and Drug Administration (U.S. FDA) and European regulatory agencies under the EU Medical Device Regulation (EU MDR) - Regulation (EU) 2017/745.
This position provides technical documentation...