Analytical, inquisitive and dynamic Regulatory Affairs/Quality Assurance Manager with 19 comprehensive years of experience working with regulated medical devices in Northern NJ area. Highly effective at maintaining regulatory compliance and managing all QMS requirements. Responsible for all areas of RA/QA, including but not limited to Regulatory Audits, Inspections, and Investigations, Customer and Supplier Audits, Quality Agreements, Change Control, CAPAs & Complaint Process, Recalls, Document Management, and Global Product registrations.Valuable, efficient, and successful at working collaboratively with cross-functional internal departments and external contacts such as Notified Bodies and USA FDA. Lead auditee/auditor for regulatory inspections and audits (i.e. EN/ISO 13485, 21 CFR 820, CMDR). Knowledge of 510(k) submissions and NB Technical File submissions for CE Mark. Contract manufacturing / Design and Development.Clinical laboratory back ground in blood banking / transfusion medicine / immunohematology.