Director, CDx Regulatory Consultant

Precisionmedicinegroup · Luxembourg · Remote-friendly

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Company
Precisionmedicinegroup
Location
Luxembourg
Posted
August 31, 2026

About this job

Position Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. This role will translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.

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