Job Summary
A clinical testing network has an open position for a Remote Research and Development In Vitro Diagnostic Development Leader in San Juan Capistrano.
Core Responsibilities of this position include:
- Supporting commercial launch of IVD products
- Driving new in vitro diagnostic product introduction to completion
- Launching assays to comply with the FDA Regulation standards
Must meet the following requirements for consideration:
- BS or MS in molecular diagnostics, molecular biology, engineering, or related field
- A minimum of 2 years within the companion diagnostic Rx-Dx interface
- 5 years’ experience in device design control responsibility in the medical device space
- Solid understanding of Class II/III product development process
- Solid understanding of global regulatory operational requirements (FDA, EMA, cFDA, etc)
