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Summary The Manager, Regulatory Affairs will provide management and hands-on support with respect to overall regulatory compliance to FDA and other applicable governmental regulatory requirements in medical devices. Main Activities/Responsibilities Function as a team member to ensure Drive DeVilbiss and its suppliers are in full compliance with FDA QSR and other international applicable regulations, including FDA establishment registration requirements. Ensure that all Drive DeVilbiss products are in full compliance with FDA and other federal, state and international regulatory requirements, including Device Listing. Review and approve labeling and promotional materials for regulatory compliance