Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing and offered plans/strategies (if appropriate) for changes that do not require submissions. * 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. * Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and instructions for use to reflect the current state of product knowledge. * Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971, …
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