Job Description
📋 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.
