Clinical Research Scientist - Medical Affairs
Core
Design and deliver clinical evaluation activities and regulatory documentation for AI medical devices to support skin cancer diagnosis pathways.
Role type
Clinical Research Scientist (Medical Affairs)
Builds
Clinical Evaluation Plans (CEPs), Clinical Study Reports (CSRs), and Clinical Evaluation Reports (CERs) for regulatory submissions.
Domain
Healthcare / Dermatology / AI Medical Devices
Deliverable
production ML models
Required skills
Medical writing, systematic reviews, meta-analyses, regulatory documentation (EU MDR, FDA), statistical methods, literature search, project management
Preferred skills
Statistical programming (R, Python, Stata), familiarity with quality management standards (ISO 13485), RAPS certification
Technologies
EndNote, Mendeley, Google Suite
Responsibilities
Design evidence generation activities, conduct SOTA literature reviews, support regulatory submissions, write CERs, collaborate on technical documentation, publish clinical data.
Seniority
Mid-Senior, hands-on IC
