Schedule: Monday – Friday (40 hrs/wk)
8:00 AM – 5:00 PM
Department: PharmaDx – 506
Primary Purpose:
The PharmaDx Quality and Regulatory Affairs Project Manager supports the development and submission of companion diagnostics (class III medical devices) to the FDA and other regulatory bodies for approval and/or supports the PharmaDx quality management System (QMS). The PharmaDx Quality and Regulatory Affairs Project Manager creates, gathers, and compiles the regulatory documentation to support medical device submissions. The PharmaDx Quality and Regulatory Affairs Project Manager researches regulatory requirements to support device development or clinical trial planning for FDA, EU IVDR,… Click here to view original post
