Schedule: Monday – Friday (40 hrs/wk)
8:00 AM – 5:00 PM
Department: PharmaDx – 511
Primary Purpose:
The PharmaDx Regulatory Affairs Specialist I supports the development and submission of lab developed tests and companion diagnostics (class III medical devices) to the FDA and other global regulatory bodies for in vitro diagnostic (IVD) approval and/or performance of clinical trials. The PharmaDx Regulatory Affairs Specialist I supports IRB/ethics approval applications, continuing reviews, and decisional support. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP) and risk management. The Specialist I serves as regulatory affairs… Click here to view original post
