Medical Device & Diagnostics
Director, Regulatory and Clinical Affairs, Diagnostics
Lead the regulatory and clinical path for a blood-based cancer detection test moving toward premarket approval. This role owns the FDA strategy and the clinical validation study behind it.
A typical mandate
The company runs a CLIA-certified, CAP-accredited laboratory offering blood-based tests for cancer detection. It is pursuing FDA premarket approval for its lead assay to support broader coverage. The PMA strategy and the clinical validation study design are the first priorities for this hire.
What the role owns
- Own FDA regulatory strategy, including pre-submission meetings and the PMA pathway
- Design and oversee the clinical validation study with clinical, biostatistics and laboratory teams
- Prepare analytical and clinical sections of the PMA and agency responses
- Keep regulatory work aligned with the QMSR and ISO 13485 quality system
- Advise on international regulatory pathways as the company plans its next markets
- Lead a small team of regulatory and clinical affairs specialists
What great candidates bring
- Advanced degree in a life science or engineering discipline
- 10+ years in IVD regulatory or clinical affairs
- Direct PMA or De Novo experience with an in vitro diagnostic
- Experience designing prospective clinical studies for diagnostic tests
- Working knowledge of CLIA, CAP and the QMSR
- Oncology or screening test experience preferred
Why it matters
- Reports to the Chief Medical Officer
- Equity and annual bonus
- A central role in the company's most important regulatory milestone
- Hybrid schedule
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