Multi-dimensional competency assessment for the Regulatory Affairs Specialist role — Cognitive Aptitude (numerical & logical reasoning), Role Knowledge, Situational Judgement. Proctored; produces a competency profile, not a single MCQ score. Skills assessed: Regulatory submission preparation, FDA 21 CFR compliance, eCTD dossier compilation, labeling review and approval, medical device registration, EU MDR/IVDR knowledge, regulatory intelligence research, adverse event reporting systems.
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