Serve as an internal Regulatory advisor/consultant for Medtronic Spine & Biologics providing stratigic Regulatory guidance to the various therapy segments. Serve as the Regulatory lead for Business Development due diligence iniatives.

Develop regulatory strategy for thoracolumbar, cervical and biologic projects; Work with product development management and key surgeon/inventors on development of new technologies and determining the appropriate regulatory pathway; Arrange and lead face-to-face Pre-IDE meetings with FDA; Author literature reviews to support clinical submissions (20 per year); Oversee all down classified interbody cage submissions; and oversee regulatory compliance at national and international tradeshows where Medtronic Sofamor Danek is an exhibitor (e.g. American Academy of Orthopedic Surgeons, North American Spine Surgeons, Scoliosis Research Society and International Congress Early Onset Scoliosis).Accomplishments:Obtained more than 125 Medtronic Sofamor Danek Spinal 510(k) applications clearances.Developed regulatory strategy which eliminated the need for eight clinical trials. This resulted in sixteen 510(k) clearances. Elimination of these trials created a cost savings of six to nine million and allowed product to reach market three to four years earlier than originally projected. These clearances generated more than 180 million in revenue. Named Technical Contributor of the Year in 2001 by Medtronic for regulatory work in obtaining clearance of a key product line.Recipient of the 2005 Circle of Excellence Award by Medtronic Sofamor Danek for obtaining strategic clearances of unique devices. Guest auditor for Medtronic corporate dedicated to auditing the Regulatory Affairs, Clinical and Quality departments at various divisions such as Medtronic Canada and Cardiac Rhythm Disease Management.

Researched and authored FDA application which resulted in the Agency's first specific clearance of pedicle screw usage to treat adolescent idiopathic scoliosis in pediatric patients and resulted in the establishment of a new FDA product code: OSH

Retained as the primary Regulatory Affairs consultant for Plexus Biomedical in Oakland, TN.

Develop Regulatory pathway strategy for new technology products. Serve as Regulatory consultant for this OBGYN company.

Co-authored 510(k) submission which resulted in the first and to date only FDA clearance of pedicle screws for usage in the posterior cervical spine.

Developed and implemented the company's first central documentation system. Served as an internal and supplier auditor as well as co-host for FDA site audits. Along with writing document control and quality procedures, helped develop the Wright Medical Technology Quality Manual and assisted engineers in developing and writing departmental procedures.