Backed by more than three decades of progressive regulatory and business management experience in the pharmaceutical and medical device industry, Ally Xu brings in-depth knowledge of regulatory, clinical and quality management to her role as Director of Quality Assurance and Regulatory Affairs at HepQuant.
With broad range of experiences and academic credentials in regulatory, quality operations and clinical evaluations, including pre-market submission, post-market surveillance and reporting, Ms. Xu has hands-on authoring and reviewing experience of regulatory documents critical to the submission of IDE, PMA, 510(k), ANDA, IND and NDA in the US and Technical File/Documentation in EU.
Ms. Xu most recently served as Regulatory Lead at CONMED, a global medical technology company specializing in the development and sale of surgical and patient monitoring products and services that allow physician customers to deliver high quality care and enhanced clinical outcomes for their patients. On behalf of CONMED, she authored 510(k) submissions and MDD/MDR technical files for electrosurgical software-supported systems and insufflation devices for minimally invasive surgical procedures, including robotic, endoscopic and open surgical procedures. She assisted in regulatory submissions around the world including Canada, Japan, China and other international markets.
Prior to CONMED, Ms. Xu served as Manager, Regulatory Affairs at Terumo BCT, a global leader in medical device and combinational product development and manufacturing, where she led a team of regulatory professionals, supporting EU Technical Files and APAC registrations for Class IIb and Class III sterilized disposable sets, software-supported medical equipment, stand-alone software (SaMD), combination products and solutions (considered drug or device depending on countries).
She started her career at the Guangdong Institute for Drug Control, GDFDA, the Chinese regulatory authority similar to the FDA in the US. Before her Terumo BCT tenure, Ms. Xu served in different regulatory affairs roles at different sizes of medical device and pharmaceutical companies including BD Pharmaceutical Systems, Ferguson Biotechnologies, Baxter Healthcare and Glaxo-SmithKline.
At Ferguson Biotechnologies, Ms. Xu led the regulatory affairs, drug and nutritional product development and quality functions, developing generic drug products for the US, international markets and China and providing contract drug, device and nutritional products manufacturing services to international partners.
Ms. Xu graduated from Shanghai Medical College of Fudan University in Shanghai, China, where she earned a Bachelor of Science degree in Pharmacology (equivalent to the Pharm.D in the US). She completed a Master of Business Administration from Marshall School of Business in the University of Southern California (USC). She was the Distance Educational Program Manager for the Regulatory Science Program in the School of Pharmacy in USC and was also accepted as a master.