Principal Regulatory Affairs Manager - Mettawa, IL
3 weeks ago

Job summary
The Principal Regulatory Affairs Manager is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment.
Responsibilities
- The Principal Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment
- The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and submissions to support product commercialization in multiple regions (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA)
Job description
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