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 | 2026-01-05 |