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Principal Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences
📍
Waukegan, Illinois, United States
Location
Waukegan, Illinois
Posted
May 16, 2026
Commute
Local Area
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Job Description
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) and will mentor the organization in these key activities
- The Principal Regulatory Affairs will work with Biopharma partners to develop and deploy CDx regulatory strategies
- In this role you, will work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development an...