A Regulatory Affairs and Quality Systems professional in the medical device industry for over 25 years, Raymond Ursick has specific skills with regard to FDA regulations and international medical products regulations, regulatory affairs, regulatory compliance, ISO 9001 and ISO 13485, quality systems, and Total Quality Management (TQM). He has obtained FDA regulatory approvals for diagnostic imaging devices, neurological devices, cardiovascular devices and cardiovascular implants, sterilization devices and other infection control devices, surgical devices, dental devices, general hospital and personal use devices and critical care monitoring devices. Additionally, he has led successful programs to achieve ISO 9001 and ISO 13485 certification, to obtain CE Marking and to achieve Quality Awards using Malcolm Baldrige criteria.
Prior to beginning his consulting practice Raymond worked at Johnson & Johnson for eighteen years at three different operating companies, where he held various executive positions in Regulatory Affairs and Quality Systems. He then worked at STERIS Corporation for six years in the position of Vice President Regulatory Affairs and Quality Systems.