Director, CDx Regulatory Consultant

📋 Description

• Serve as the CDx regulatory SME for strategic client programs and pathways.
• Lead global CDx regulatory strategies and submission roadmaps.
• Collaborate cross-functionally with development, QA, and commercial teams.
• Develop integrated Rx Dx regulatory strategies aligning milestones.
• Advise on regulatory use of assays in trials (patient selection, IRB, IDEs).
• Direct global submissions for CDx and trial assays (FDA Q-Submissions, IDEs, PMAs).

🎯 Requirements

• Bachelor’s degree in life sciences or related; equivalent experience.
• Minimum 5 years of consulting in IVD/CDx/regulatory affairs.
• Minimum 7 years in an IVD/regulatory environment.
• Direct experience with diagnostic manufacturers and pharma sponsors.
• Strong written and verbal communication; translate complex regs to practical recs.
• RAC certification preferred.