Director, Global CDx Regulatory Strategy

Precision Medicine Group; United States; Remote; USD 162,000 - 243,000; Full time

Job summary

Precision Medicine Group seeks a Director, CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA and EU IVDR requirements into practical plans for development, submission, and lifecycle management across partners.

The role collaborates with therapeutic development, diagnostics manufacturers, and quality teams to align regulatory strategy with program milestones, timelines, and commercialization objectives.

Qualifications

• Bachelor’s degree in life sciences, regulatory affairs, or related field.
• Minimum 5+ years of applicable consulting experience in IVD or CDx regulatory affairs.
• Master’s degree and RAC certification are preferred.

Responsibilities

• Serve as the CDx regulatory SME for strategic positioning of client programs inclusive of CDx, including relevant FDA precedents, EU IVDR considerations, global submission expectations, and diagnostic commercialization pathways.
• Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives.
• Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives.
• Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.
• Develop integrated Rx Dx regulatory strategies that align diagnostic development, biomarker strategy, clinical trial enrollment, therapeutic development milestones, and commercialization objectives for pharmaceutical, biotechnology, and diagnostic clients.
• Advise clients on regulatory requirements for use of assays in clinical trials, including patient selection, inclusion or exclusion testing, significant risk and nonsignificant risk determinations, IRB considerations, investigational device requirements, and global performance study obligations.
• Direct the preparation of global regulatory submissions and supporting documentation for companion diagnostics and clinical trial assays, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, EU IVDR Annex XIV performance study applications, technical documentation, and other country-specific submissions.
• Lead interactions with regulatory authorities and notified bodies, including preparation for FDA meetings, interpretation of agency feedback, development of response strategies, meeting minutes, and follow‑up communications on behalf of clients.
• Review and direct the development of analytical validation plans, clinical performance study plans, diagnostic clinical protocols, statistical analysis synopses, technical reports, intended use statements, labeling, and other submission‑ready documents for CDx programs.
• Apply IVD quality system, design control, risk management, and post‑market regulatory expertise to support CDx readiness from early development through approval, launch, and lifecycle management.
• Stay current on CDx regulatory, scientific, and market developments, including FDA guidance, EU IVDR implementation, notified body expectations, global regulatory trends, diagnostic precedents, and evolving precision medicine requirements.

Skills

CDx regulatory strategy

FDA knowledge

Regulatory submissions

Client advisory

Cross-functional leadership

Education

Bachelor's degree in life sciences

Master’s degree (preferred)

Job description

Precision Medicine Group seeks a Director, CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA and EU IVDR requirements into practical plans for development, submission, and lifecycle management across partners.

The role collaborates with therapeutic development, diagnostics manufacturers, and quality teams to align regulatory strategy with program milestones, timelines, and commercialization objectives.