Principal Clinical Scientist
Core
Design clinical studies and evidence strategies to support global regulatory submissions for diagnostic modalities in the US and EU.
Role type
Principal Clinical Scientist (Regulatory Strategy)
Builds
Clinical evidence packages and regulatory documentation for diagnostic products
Domain
Life Sciences / Clinical Diagnostics / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design, Regulatory strategy (FDA 510(k)/PMA, CE IVDR), Cross-functional partnership, Scientific data interpretation, Protocol development, Mentorship
Preferred skills
IVD study design, Hematology and Urinalysis domain expertise, Professional certification (SoCRA, ACRP)
Technologies
FDA 510(k), PMA, CE IVDR
Responsibilities
Design clinical studies and evidence strategies, Act as liaison with regulatory bodies and KOLs, Partner with R&D and Commercial teams, Author and review clinical/regulatory documentation, Mentor junior scientists
Seniority
Principal, strategy & mentorship