Regulatory Affairs Specialist

Description:

Must have list:

1. In vitro diagnostics regulations in precision medicine under US and EU regulations

2. Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements

3. Has built a diagnostic device regulatory strategy plan for a biomarker-driven trial

4. Kept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drug trial