Gloria M. Ferko
Head of Quality and Regulatory Affairs
Ms. Ferko is a biotechnology senior professional with over 20 years’ experience encompassing the regulatory and compliance (GxP) aspects involved in the development and commercialization of medical and diagnostic devices.
She has a track record of accomplishments in the definition and execution of regulatory strategies, especially those pertaining to Quality System management, regulatory affairs, and the strategic planning and execution of preclinical and clinical development programs. Ms. Ferko brings Cerora her specialized skills in design control, risk management, manufacturing, project management, as well as the writing and review of documentation for submission to FDA, obtaining ISO 13485 /CE Mark certification.