July 31, 2013 – RAPS RAC preparation webcast creation and presentation – US Medical Device RegulationsJuly 15, 2015 – RAPS RAC preparation webcast creation and presentation – Clinical ConsiderationsJuly 13, 2016 – RAPS RAC preparation webcast creation and presentation – Clinical Considerations IJuly 20, 2016 – RAPS RAC preparation webcast creation and presentation – Clinical Considerations II

• Operations, Quality and Regulatory Leadership- FDA Official Correspondent, ISO 13485 Management Representative and Senior Management team member- Responsible for all activities related to FDA’s QSR, ISO 13485:2003, CE Mark registration, Notified Body and Authorized Representative correspondence for Medical Device Directive (EU) activities, CMDCAS registration and licensing and also host for FDA, ISO and contracted audits.

As the original QA/RA employee and as a member of the Senior Management Team, created,implemented and oversaw an ISO 9001 compliant quality system, hired department employees, and communicated with vendors in China, Arizona, Maryland, and Florida.