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

Organization Athsai
Industry Other Jobs Jobs
Occupational Category Regulatory Affairs Specialist
Job Location London,UK
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Intermediate
Experience 2 Years
Posted at 2024-10-11 5:56 pm
Expires on 2025-01-21