Carol Chen

Regulatory Affairs Specialist

Carol Chen, PMP is a Regulatory Affairs Specialist at Stryker since November 2021, managing regulatory submissions for trauma and extremities business units and overseeing the annual MDL renewal process. Previous experience includes a role as a Regulatory Specialist at Quality Smart Solutions, where regulatory and quality submissions were prepared for various device classes and communication with regulatory agencies took place. An internship at AceAge involved assisting in regulatory submissions for FDA and Health Canada and supporting quality assurance efforts. Carol holds a Master's degree in Biotechnology from the University of Guelph and a Bachelor's degree in Physiology/Human Biology from the University of Toronto, complemented by research experience in various medical and scientific settings.

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