25 yrs experience with medical devices and in vitro. Regulatory Affairs Certified RAC. Accredited by ANSI-RAB. ISO 13485. FDA 510(k). 21 CFR 820.

25 years of experience in FDA regulated industry (medical devices and in vitro diagnostics). • Demonstrated record of achievement in domestic and international regulatory submissions. • Classification, conformity assessment and technical documentation for CE marking of multiple products regulated under the Medical Devices and In Vitro Diagnostic Medical Devices Directives. • Successful management of FDA inspections and Notified Body audits of the quality management system. • Broad experience wit...

25 years of experience in FDA regulated industry (medical devices and in vitro diagnostics). • Demonstrated record of achievement in domestic and international regulatory submissions. • Classification, conformity assessment and technical documentation for CE marking of multiple products regulated under the Medical Devices and In Vitro Diagnostic Medical Devices Directives. • Successful management of FDA inspections and Notified Body audits of the quality management system. • Broad experience with multiple FDA product classifications: cardiovascular, nuclear medicine, general surgery and orthopedic medical devices; clinical chemistry, microbiology, immunology and hematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping). • Direct experience assisting manufacturers to achieve certification to ISO 13485 : 2003. • Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society in both United States and European Union regulatory affairs. • Accredited lead auditor for medical device quality systems by ANSI-RAB. I enjoy the challenge of aligning the research, regulatory, quality, clinical and marketing plans with the shared goal of delivering to the marketplace validated products that benefit both the patient and the clinician.