MedCon Strategic Committee Members
Past and Present

  • Steve Binion, Ph.D.
    Director Regulatory Affairs/Corporate Clinical Development
    Becton Dickinson
  • Francis Blacha
    Global Quality Leader – Devices
    Eli Lilly and Company
  • Gina Brackett
    Compliance Officer and Medical Device Performance Auditor, Cincinnati District Office
    U.S. Food and Drug Administration.
  • Paul Brooks
    Vice President, Country Manager, U.S.
    BSI
  • Maria Cianciotto
    Managing Partner
    Quality Systems Architects
  • Karen Coleman
    Expert Consultant
    Former FDA National Device Expert and GHTF Representative
  • Chitra Edwin
    President
    Biotechnology Consulting Solutions
  • Barbara Fant, Pharm.D
    Principal Regulatory Consultant and President
    Clinical Research Consultants, Inc.
  • Lenore Faulhaber, Ph.D.
    Senior Scientist
    Procter & Gamble Co.
  • Danielle Giroud
    Founder
    World Medical Device Organization – Switzerland
  • Dennis Hahn
    Director, Regulatory Strategic Initiatives, Ethicon Endo-Surgery
  • Barbara Immel
    President
    Immel Resources LLC.
  • Teresa Jimenez-Valentin
    Expert Consultant
    Regulatory Expert Consultants – Puerto Rico
    Former FDA National Device Expert
  • Michael Marcarelli, PharmD, MS
    Director, Division of Bioresearch Monitoring. Office of Compliance
    FDA Center for Devices and Radiological Health
  • Steve Marcello, MD
    Director Medical Affairs
    Ethicon Endo-Surgery
  • Christine Nelson
    Expert Consultant
    Former FDA GHTF Representative
  • Steve Niedelman
    Lead Quality System & Compliance Consultant
    King & Spalding
    Former FDA Deputy Associate Commissioner
  • Phil Pontikos
    National Device Expert
    U.S. Food and Drug Administration
  • Jim O’Reilly, JD
    Professor of Law
    University of Cincinnati
  • Susan Rolih
    Senior Vice President Regulatory Affairs/Quality Assurance
    Meridian Bioscience, Inc.
  • Heather Rosecrans
    Senior Regulatory Advisor, Greenleaf Health, LLC
  • Tom Ruthemeyer
    Clinical Professor (Graduate Program)
    Xavier University
  • Nancy Singer
    Founder, Compliance Alliance
  • Ken Sumner, Ph.D.
    Worldwide Vice President of Clinical & Regulatory Affairs
    Ethicon Endo-Surgery, Inc.
  • Wendy Turner
    Director, Regulatory Affairs
    Ethicon Endo-Surgery
  • Sheri Uber
    Clinical Research Manger
    Cincinnati Children’s Research Foundation
  • Monica Wilkins
    Divisional Vice President, Quality Assurance/Regulatory Affairs
    Abbott
    Former FDA National Device Expert