The incumbent facilitates the development, maintenance, and archiving of documents that capture the research, development, and transfer activities of the Company. R&D. The IVD Documentation Specialist relies on a combination of biomedical education, IVD/Class III medical device development regulations, processes, and labeling requirements, and technical writing expertise to help design departmental templates, create and maintain SOP's, edit protocols and reports, develop/draft manufacturing documents, and develop and maintain end-user labeling.