Director of Quality and Regulatory Affairs
Connie assures company compliance with country regulatory requirements such as Quality System Requirements and 510(k) submissions for US, Medical Licenses for Canada, and CE Mark / IVDD / MDD for European countries. She was previously the Director Quality & Regulatory Affairs at Siemens Medica l/ Draeger Medical where she had overall responsibility of the Quality System and regulatory requirements. Connie has also held various quality and regulatory management roles for BVQI, KPMG, Baxter Health Care and Instrumentation Laboratories over the last 25 years. She holds a B.S. Medical Laboratory Science from Northeastern University in Boston.