Principal Clinical Scientist
Core
Designing clinical trial strategies and evidence plans for diagnostic tools to support regulatory submissions and product clearance in the US and EU.
Role type
Principal Clinical Scientist (Strategy & Regulatory)
Builds
Clinical study protocols, evidence plans, and regulatory documentation for diagnostic devices.
Domain
Medical Diagnostics / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and methodology, Regulatory compliance (FDA 510(k)/PMA, CE-IVDR), Scientific data interpretation, Cross-functional collaboration, Protocol development, Evidence strategy
Preferred skills
IVD study design (Clinical Chemistry, Immunoassays, Hematology, Flow Cytometry), Advanced degree in Science/Regulatory Affairs, Professional certification (SoCRA, ACRP)
Technologies
FDA 510(k), PMA, CE-IVDR
Responsibilities
Design clinical studies and evidence strategies for global regulatory submissions, Act as scientific liaison with regulatory bodies and key opinion leaders, Partner with R&D and Commercial teams to align clinical programs, Author and review clinical and regulatory documentation, Mentor junior scientists and maintain expertise in evolving standards
Seniority
Principal, strategy & mentorship
