Arlene has over 18 years of experience in Regulatory Affairs & Quality Management, Engineering, and Manufacturing in an FDA- and ISO-regulated medical environment. She has worked for organizations such as Siemens Medical Oncology Care, Philips Healthcare, and Celera Diagnostics. Arlene has experience in the development and maintenance of various Product Technical Files and Design Dossiers, FDA 510(k)s, Health Canada submissions, and various global registration activities. Arlene graduated from City University of New York, City College with a B.S. degree in Electrical Engineering.