Experienced Quality/Regulatory leader in the medical device industry, significant experience with FDA and international registrations for Class 1, 2, and 3 devices. Successful achievement of 510(k) and PMA clearance/approvals, Design Dossier reviews by EU Notified Bodies, and individual country registrations in Eastern Europe, Africa, Middle East, and Asia Pacific. Many years of increasing responsibility for product quality in both manufacturing and product development. Experience with FDA 483 and Warning Letter responses and development of remedial action plans. Complete understanding of regulatory compliance requirements for both FDA QSR and ISO 13485.