Responsibilities: Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product. Must attend multiple weekly meet...
. General Overview The Expedited Specialist II will conduct reviews of submitted human subject research applications in... submissions, training requirements, and updated processing procedures. The Expedited Specialist II independently understands...
Safety, Regulatory Affairs and Medical Affairs Lead and participate in activities that ensure quality, consistency... phases of clinical development (Phase II-III). This includes literature research and frequent interaction with internal...