Clinical Development Scientist, Computed Tomography
Core
Analyze clinical studies and protocols for medical devices to ensure regulatory compliance and data integrity while developing Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and regulatory submissions.
Role type
Senior Clinical Development Scientist (Medical Devices)
Builds
Regulatory submissions, Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Reports, and scientific publications.
Domain
Medical Devices / Computed Tomography / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data analysis, Clinical Evaluation Report (CER) authoring, Post-Market Clinical Follow-Up (PMCF) reporting, regulatory compliance (EU MDR, GCP, ICH), cross-functional collaboration, project management
Preferred skills
Biostatistics application, statistical software proficiency, MEDDEV 2.7.1 Rev. 4 experience, KOL relationship cultivation, innovative clinical study design
Technologies
Statistical software, medical and scientific literature databases
Responsibilities
Collect, appraise, and analyze clinical data for medical devices; Write CERs, PMCF Reports, and CSRs for regulatory submissions; Collaborate with internal and external partners for comprehensive evidence analysis; Create procedures and workflows for the Clinical Development department.
Seniority
Mid-Senior, hands-on IC