Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing and offered plans/strategies (if appropriate) for changes that do not require submissions. * Advises of regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. * May identify, monitor, and submit relevant reports (e.g., Serious Adverse Events) or notifications (e.g., changes in manufacturing) to regulatory authorities during the clinical research process. * Provides regulatory input and support and, as necessary, follow-up for inspections and audits. * Tracks and assesses the scientific and clinical advances that impact healthcare product development and regulations. * Participates in targeted education, clinical science, and evolving science study to meet regulatory requirements for emerging technologies.
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