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Senior CDx Regulatory Strategy Lead

Job in Frederick, Frederick County, Maryland, 21701, USA
Listing for: Precision For Medicine
Full Time position
Listed on 2026-07-13
Job specializations:
  • IT/Tech
Salary/Wage Range or Industry Benchmark: 162000 - 243000 USD Yearly USD 162000.00 243000.00 YEAR
Job Description & How to Apply Below

Precision for Medicine seeks a Director-level CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA, EU IVDR, and other requirements into practical plans, working with pharmaceutical and diagnostic clients to enable regulatory approvals and lifecycle management.

The role emphasizes leadership across cross-functional teams, development of submission roadmaps, and engagement with regulatory authorities.

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Position Requirements
10+ Years work experience
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