Clinical Assessor
Core
Review and assess Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and supporting clinical evidence to evaluate the adequacy, scientific validity, relevance, and consistency of clinical data supporting device safety, performance, and clinical benefit.
Role type
Senior Clinical Assessor (Medical Devices)
Builds
Evidence-based assessment reports and conclusions for medical device conformity
Domain
Medical Devices / Regulatory Affairs
Required skills
Clinical medicine background, Critical appraisal of scientific literature, GCP knowledge, Clinical research study design, Regulatory non-conformity identification, English technical documentation review
Preferred skills
Medical device regulatory frameworks (MDR/IVDR), ISO 13485, PMCF/PMPF documentation experience, Therapeutic area expertise
Responsibilities
Review and assess Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs), Critically appraise scientific publications and clinical investigation reports, Identify gaps and regulatory non-conformities in submitted documentation, Prepare clear and technically sound assessment reports, Participate in multidisciplinary MDR/IVDR conformity assessment teams
Seniority
Senior, hands-on IC