Clinical Scientist
Core
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) to support CE Mark applications and EU market clearance for medical devices.
Role type
Senior Clinical Scientist (Medical Device Regulatory)
Builds
Clinical evaluation documentation (CEPs, CERs) for regulatory submissions
Domain
Medical Devices / Regulatory Affairs / Clinical Evaluation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical evaluation planning, medical writing, literature search and appraisal, regulatory compliance (EU MDR, GCP), risk assessment, protocol development, cross-functional collaboration
Preferred skills
Clinical Evaluation Report (CER) writing experience in medical device industry
Technologies
Project management tools
Responsibilities
Develop and author CEPs and CERs for regulatory submissions; conduct comprehensive literature searches and critically appraise scientific data; respond to regulatory authority inquiries; manage CEP/CER timelines; support clinical study protocols and reports; provide clinical perspective for new product development
Seniority
Senior, hands-on IC