Intuitive Surgical, Inc
Director of China/HK RA/QA
Qianquan serves as a pivotal link between Intuitive’s RAQA department and the IntuFosun RAQA team—a joint venture between Intuitive and Fosun. She plays a crucial role in developing localization strategies, negotiating support, and executing plans for in-country manufacturing transfer, regulatory approvals, and registrations. Prior to her current role, she excelled as the Director of International Regulatory Affairs at Immucor, Inc., managing international regulatory requirements, including product registration, importation compliance, and post-market vigilance.
• 11+ years of working experience of global regulatory affairs, include China NMPA registration, covering type test and clinical trials
• Proven track record of Class III MD, IVD and Drug approvals in China
• Worked with CMDE on the drafting and releasing of 10+ technical review guidance
• Worked with BIMT and NIFDC on varies national standard and reference material development
• RAC Global certified in 2016
• Practiced Law and International Trade in China and the UAE prior to coming to the U.S.