Ustar is a raising high-tech company in IVD(in-vitro diagnostic) industry dedicating to bring innovative point-of-care molecular diagnostic tools that no longer rely on expensive equipment and a molecular lab.Over all take charge of new product registration and take into account the quality system building and running based on ISO 13485.Provide regulatory advice and consultation for company strategic planning and compliance issue.Manage, coach and guide registration team, help to prepare training plan for the team member.

In charge of the registration of total 50+ products, includes the products transferred from oversea plant. Acquired 25 registration certificates and completed 40+ products’ clinical trial on schedule.Established high-performance internal work procedure and dynamic team, dealt with government supervision and QS audit 2~3 times per year.