Sanja Matern holds a PhD degree in biology with a focus on molecular biology and biochemistry at the University of Heidelberg, Germany. Additionally, she specialized in regulatory affairs at Luebeck University, Germany. Since 2017, she has worked in several regulatory affairs positions in the IVD industry, focusing on IVDR implementation.
Dr. Matern currently serves as head of product group regulatory affairs, working on IVD product registration with the FDA, NMPA, and Notified Bodies, regulatory authorities in the U.S, China, and EU. She is active in MedTech Europe and represents Siemens Healthineers on the Regulatory Affairs Committee (IVD). She is experienced in assessing the conformity of hemostasis assays, plasma proteins/clinical chemistry, and infection parameters with the requirements of different notified bodies and successfully led the IVDR certification of Siemens Healthineers hemostasis product line.
Sunday, July 10, 2022
12:20 PM – 12:30 PM
Sunday, July 10, 2022
12:40 PM – 12:55 PM