Director, CDx Regulatory Strategy

Precisionmedicinegroup

Germany (OH)

On-site

USD 150,000 - 230,000

Full time

14 days+

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Job summary

Precision Medicine Group is seeking a Director, CDx Regulatory Consultant to advise clients on CDx regulatory strategy, IVD development, and lifecycle management. You will translate FDA, EU IVDR, and global requirements into practical plans for Rx Dx co-development, biomarker strategy, and clinical trial assay considerations.

The role entails leading consulting engagements, coordinating with diagnostic manufacturers and pharma sponsors, and overseeing submissions and regulatory interactions

Qualifications

Bachelor’s degree in life sciences or related field.
Minimum 5 years consulting in IVD/companion diagnostics regulatory affairs.
Direct experience with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies.

Responsibilities

Serve as CDx regulatory expert for strategic positioning of client programs.
Lead engagements to develop global CDx regulatory strategies and submission roadmaps.
Partner with cross-functional teams to align CDx development with regulatory expectations.
Direct global regulatory submissions and documentation for CDx programs (FDA, EU IVDR, etc.).
Lead client workshops and educational sessions on CDx development and regulatory requirements.

Skills

CDx regulatory

FDA regulatory

EU IVDR

Regulatory submissions

Clinical trial assays

Education

Bachelor’s degree in life sciences

Master’s degree or higher

Job description

The role entails leading consulting engagements, coordinating with diagnostic manufacturers and pharma sponsors, and overseeing submissions and regulatory interactions

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