Extensive global experience working in several industries; since 1991 in medical products(pharmaceuticals,devices,diagnostics) in quality assurance,regulatory and clinical affairs.Have been responsible for multi-site operations, corporate staff functions, global GMP compliance, acquisition evaluation, regulatory submissions,regulatory influencing functions (FDA, Notified Body,EMA), clinical program development and management. Solid international reputation in developing and implementing positive quality systems and regulatory strategies while building credibility with regulatory agencies. Have managed teams from 5 to 127 professionals.
Specialties: Full spectrum of medical products quality and regulatory management from concept through clinical to manufacturing and post-approval support.Particular expertise in drug/device combination products - regulatory strategies and cGMP's. Have worked with transdermal, pulmonary, surgical sealants,surgical implants, hemostats, IVD's, pharmaceuticals, and various drug delivery platforms.