Director, CDx Regulatory Consultant

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, CDx Regulatory Consultant based in United States. The Director, CDx Regulatory Consultant will provide strategic regulatory leadership for companion diagnostics (CDx), in vitro diagnostics (IVD), and precision medicine programs across global markets. This role will guide pharmaceutical, biotechnology, and diagnostic organizations through complex regulatory pathways, from early development strategy to commercialization and lifecycle management. The position requires deep expertise in FDA, EU IVDR, and international regulatory frameworks, combined with strong consulting and client engagement capabilities. The successful candidate will translate scientific, clinical, and regulatory complexities into actionable development plans that accelerate patient access to innovative therapies. Working with multidisciplinary teams, this leader will shape regulatory strategies, support high-impact programs, and contribute to the growth of a specialized precision medicine consulting practice.