Years of experience: 22

United StatesPresentation DesignerIllustratorBrand DesignerCommunication DesignerGraphic Designer

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Duan's Career Path
Product Labeling SupervisorSep. 2023 -
Present
STERIS EndoscopyProduct Labeling Supervisor
Conroe, Texas, United States• Provide direction on label management processes and project prioritization and execution. • Create and modify labeling for product instruction for use (IFU) documents, labels, cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelin...
Senior Regulatory Consultant, IVDJul. 2021 -
Jul. 2023
NAMSASenior Regulatory Consultant, IVD
Minnesota, United StatesExamined and assessed various clients IVD medical devices for compliance to FDA and EU regulations, for the marketplace. Provided comprehensive details regarding investigational product(s) and high level understanding of the IVD medical device development process. Delivered strategic direction and guidance for NAMSA clients, particularly as it relates to product development. • Assessed IVD de...
Sr. Regulatory Affairs Specialist, LabelingJun. 2016 -
Jul. 2021
Sysmex America, Inc.Sr. Regulatory Affairs Specialist, Labeling
Lincolnshire, ILThe Sr Regulatory Affairs Specialist is responsible for supporting compliance to FDA, Canada and Latin America regulations, listings and licenses and applicable international regulations. The individual will coordinate, compile, and submit regulatory documents to FDA and other appropriate regulatory agencies according to requirements. The individual will provide support for all regulatory com...

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