Senior Regulatory Advisor - Start-Up Fractional CDX

Confidential oncology biotech seeking a Fractional Regulatory CDx Strategy Advisor to help shape diagnostic strategy alongside an innovative drug development programme that they have.
You'll provide expert guidance on:

Companion diagnostic (CDx) strategy
FDA pathways (PMA, Q-Sub, IDE, 510(k))
EU IVDR regulatory strategy
Oncology biomarkers and translational medicine
Molecular diagnostics, liquid biopsy and IHC assays
Global regulatory approval pathways for precision medicine products
We're looking for someone with proven CDx experience in a start-up environment. Someone who has experience taking a Companion diagnostic through the stages of approval, strong US and EU regulatory knowledge.
Flexible consultancy engagement with significant strategic influence reporting directly into the co-founder.