Xiang

Project Management - All Regulatory Affairs of medical products (active and non-active) under the brands of Aohua and its subsidiaries. 1. Supervise the registration process in the following areas, by continuous self-improvement and internal trainnings to employees: a. China: focus on testing and critical registration endpoints of both China and Germany produced devices; b. CE: kept CE Mark under MDD with another 4 years' term of validity and integrate new MDR requirements into Aohua products; c. FDA: plan to apply for 510(k) for "Disposable Endoscope Valves Kit"; d. international: 20 more countries are in the list; main markets include Brazil, Mexico, Russia and Korea. 2. Manage several NMPA registration cases by working together with MDST (Hangzhou Test Center) and Shanghai FDA, regarding to Imaging Processors and Endoscopy products. 3. Support subsidiaries in Changzhou and Hangzhou with regard to their FDA and CE applications, as well as ISO13485 on-site audits and SOP drafting. People Management - 4. Re-organized the team with a more functional structure, differentiating the local and international areas / active and non-active parts. Actively developed members who have better motivation to a higher level. The new structure made team members focus more on their own area and work more efficiently than before. 5. Focused on improving the competitive abilities of team members in RA filed by holding weekly internal trainings and daily directions. Topics range from Endoscopic standards to “How AI is used in medical industry”.

1. Introduced a mature working framework to the original zero-based international RA team. Led the team to achieve the goal of obtaining 100 licenses globally since 2014. This helped international sales to increase turnover by 100% in consecutive two years. 2. Led RA team to compile 10 CER for orthopaedics products in 2015 (MEDDEV 2.7.1 Rev. 3). 3. Created procedures of global vigilance system by co-working with Stryker EEMEA QA team. Afterwards, led a team to successfully perform the first recall from EU in one month (incorrect classification). 4. Passed more than 20 on-site QMS audits since 2014 by co-working with cross-functional teams. Auditors were coming from TUV, BSI, KFDA (Korea), Kazakhstan MOH, ANVISA and Stryker Global Internal Audit Team. 5. Attended Stryker internal Risk Management training and performed self-learning to ISO14971. Got basic understanding of how to involve RM into product life cycle.

1. Obtained more than 10 licenses in Asia Pacific by working cross functionally with global team, including RA in Japan and Australia, Marketing in Singapore, consultants and dealers throughout Asian countries.

1. Led all RA specialists in subsidiaries by supporting them to analyze their potential markets and finalize global launching plan. Created working instruction for global registration in early 2013. 2. Obtained over 50 licenses since 2008 in EU, Asia Pacific, Latin American and Eastern Europe countries by working together with multi-national dealers. International sales revenue increased 40% based on new licenses.

1. Got 3 approvals from CFDA during 2006 to 2008: one for new registration and two for renewals.

1. Assisted Clinical Specialist to distributed investigational devices, make traceability records and collect CRF from Shanghai Hospital. Around 300 samples were put into clinical investigation.