Sr. Manager Post-Market Risk Management at Ortho-Clinical Diagnostics
JOSEPH (JOE) FALVO is Sr. Manager, Post-Market Risk Management at Ortho Clinical Diagnostics. With over 31 years of industry experience in Research & Development along with Quality, Regulatory and Compliance responsibilities, Joe has managed recalls and development of worldwide recall strategies for Ortho Clinical Diagnostics for over 17 years. He liaises with numerous FDA District Offices and CDRH and CBER regarding initial and follow-up reports, as well as supports the reporting of field actions to global Competent Authorities such as MHRA (UK), ANSM, MHLW, etc. Joe expanded his responsibilities to Managing the Complaint Handling Unit in 2007, which included reportability determination, Regulatory Reporting (MDRs, Adverse Event Reporting, etc.), authoring of Health Hazard Evaluations, etc. As a recall/field action Subject Matter Expert, Joe also provides expertise to other companies.