AFDO RAPS Healthcare Products Collaborative
Jiaying Shen



Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality


Jiaying Shen, Ph.D., brings over 17 years of industry experience in pharmaceuticals and medical devices. Currently a distinguished scientist at Merck, she manages a team overseeing Design Control, Risk Management, Human Factors, and other device quality and regulatory issues for drug delivery devices. Leading multiple product development projects from pre-clinical phases to post-market support, Jiaying previously worked at Medtronic Neuromodulation R&D and Honeywell Automation and Control Laboratory after earning her Ph.D. in Industrial and System Engineering from the University of Wisconsin – Madison.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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