WuXi AppTec's Medical Device Testing business, has operating entities in both the United States and China. This division provides an integrated testing platform for medical devices which includes biocompatibility testing, chemical characterization, toxicological risk assessment, biological evaluation, large animal studies, microbiological testing, etc. The testing platform has established its China Medical Device Testing Center in Suzhou Wuzhong District with international FDA GLP, OECD GLP, CNAS, ISO13485, A2LA quality management standards and Chinese CMA and AAALAC operational standards, comprising of the outstanding International technical and management teams. At the same time, WuXi Clinical has ability to provide clinical studies and product registration services for medical devices from phrase I to IV. WuXi MedKey has rich experience in operating more than 200 medical device clinical trials and working closely with 1000 Chinese hospital clinical trial centers.

Job Location: Suzhou, China

• Support the BD Team to provide professional advises relating test strategy, sample preparation and quotation;
• Manage and communicate with clients for sample preparation, shipping plan, custom clearance and project scheduling prior to the project initiation;
• Coordinate with relevant Study Directors to ensure the project is launched and completed on schedule;
• Monitor status and report to sponsor and related personnel periodically.
• Ensure the reports delivery on time;
• Manage project changes as needed;
• Manage project meetings to facilitate the project process or discussion as needed;
• Understand the Quality philosophy based on FDA, NMPA and GLP system;
• Other duties as required.

• Master's degree in disciplines relevant to the medical industry, including but not limited to clinical medicine, biotechnology, bioengineering, biochemistry, pharmacy, veterinary, physiology, and etc.
• Previous exposure or experience in the medical device/pharmaceutical industry is preferred
• Language proficiency in both Mandarin Chinese and English