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Regulatory Affairs ManagerA Leading Regenerative Medicine Company - Canton, MAThe REGULATORY AFFAIRS MANAGER will: Manage the company's sales and marketing compliance program Review advertising and promotion materials, and those of competitors Manage the adverse event program, reviewing customer complaint investigation results; assessing and investigating potential adverse events and incident reports Manage recall and removal activities; assess and document health hazard assessments Resolve regulatory compliance issues occurring as a result of data discrepancies and manufacturing nonconformances. Support CAPA and quality investigations Review Quality Systems programs, providing regulatory SOPs to support medical device and biologics quality systems Ensure regulatory compliance with product development, validation and commercialization activities subject to US, EMEA... See job listing >28 days ago from Netshare - Save - Block - Flag - More Tools...
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