Over 25 years multidisciplinary experience in Regulatory, Clinical Affairs and Quality Systems. Specialize in creative regulatory strategies toward expedient product registrations. Many years experience and interactive skills with product design control team activities. Possess extensive knowledge and expertise for ISO 13485 and FDA compliant Quality Systems, FDA device regulations, EU Medical Device Directive (MDD), CE mark approval process, Notified Body Audits, and IRB/IDE submissions. Proficient as management representative for external regulatory and clinical contacts including FDA, Notified Body, Authorized Reps, CRO, IRB, Clinical DMB, Clinical Investigators, Central Test Labs. Appointed RAPS Fellow 2009, an achievement recognizing highly accomplished senior regulatory professionals for their continued significant contributions and leadership in the advancement of the regulatory affairs profession. Hold RAPS US Certification in 1996 and RAPS EU Certification in 2002. In 2007 winner of Leonard Stauffer award with RAPS for contributions mentoring young Regulatory Affairs Professionals. Achieved certification as Certified Quality Auditor (CQA) from American Society for Quality (ASQ) in 2006.