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Engineering / Architecture


Medical device regulation Affair Specialist
Nottingham, Nottingham



MSc Bioengineering student at University of Nottingham with experience working in the medical device industry, with an emphasis on navigating EU MDR regulations, ISO13485 and QSR 820.


  • To make the validation master plans for class IIa and class Im devices. And, discuss the testing conditions with testing laboratories like SGS and UL.


  • Cooperated with quality assurance and quality control departments to monitor IQC, OPQC, PQC, FQC, OQC’s data to ensure the device’s quality. Use 5 Why and Fishbone methods to do the Corrective And Preventive Action when there was a complain event which needs to be analyzed. 


  • Manage the whole PMS system and re-write the PMS process in our company to fulfill the requirements with MDR regulation.


University of Nottingham Master's degree, Bioengineering and Biomedical Engineering · (August 2023 - September 2024) 


Tzu Chi University Master's degree, Department of Laboratory Medicine and Biotechnology · (July 2017 - July 2018) 


Tzu Chi University Bachelor's degree, Life Science · (September 2013 - July 2017)

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