Director of International Regulatory Affairs
Immucor, Inc.
Qianqian is the Director of International Regulatory Affairs at Immucor, Inc. In this role, she is responsible for the management of international regulatory requirements, including: product registration, compliance to importation regulations and post-market vigilance. She supports cross-functional teams within Immucor for product commercialization planning and market strategies.
• 10+ 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
• Expert on China CER and PRER technical writing
• Worked with CMDE on the drafting and releasing of 7 IVD technical review guidance
• Worked with BIMT and NIFDC on varies IVD 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.
Disclosure information not submitted.
Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST