Christine Thomas

Senior VP of Regulatory & Clinical Affairs at Femasys Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
US

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Credentials

  • Lead Quality Systems Auditor
    -
  • Regulatory Affairs Certification - RAC
    RAPS
  • Six Sigma Green Belt
    -

Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior VP of Regulatory & Clinical Affairs
      • Oct 2022 - Present

    • Belgium
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Head of Regulatory Solutions North America | Senior Principal Consultant
      • Jan 2022 - Oct 2022

    • Medical Device Consultant
      • Sep 2021 - Feb 2022

    • United States
    • Medical Equipment Manufacturing
    • 200 - 300 Employee
    • Vice President Global Quality and Regulatory
      • Jul 2020 - Oct 2021

  • CE Consulting
    • Twin Cities
    • Medical Device Consultant
      • Sep 2019 - Jul 2020

  • Cardiac Science - acquired by Zoll
    • Madison, Wisconsin Area
    • Vice President of Regulatory & Clinical Affairs
      • Feb 2018 - Aug 2019

      - At the Heart of Saving Lives - - At the Heart of Saving Lives -

    • United States
    • Medical Equipment Manufacturing
    • 500 - 600 Employee
    • Vice President Quality Systems, Regulatory and Compliance
      • Jan 2017 - Jan 2018

    • Vice President Regulatory and Clinical Affairs
      • Jan 2016 - Jan 2017

      Regulatory and Clinical leader at Smiths Medical driving the strategy and execution for all business units including, Infusion Systems, Vital Care, Vascular Access and Speciality Devices. Leading global teams and driving awareness, empowerment and accountability.

    • Vice President Regulatory Affairs and Design Assurance
      • Aug 2012 - Jan 2017

      Global leader with Regulatory Affairs, International Registrations, Design Assurance including Microbiology for New Product Development and Quality Systems responsibilities in Canada, Brazil, India, Australia, and Japan. Motivated change agent with a servant leadership style focused on clear deliverables with strong accountability to invigorate staff and deliver excellence to the business.

    • Director Global Regulatory Affairs and Design Assurance
      • Feb 2011 - Aug 2012

      Leadership for sites responsible for staff, design authority and manufacturing across the USA, UK, Germany, Australia, Brazil, India, China and Japan. Responsiblie for Regualtory Affairs, global Registrations and Design Assurance for New Product Development and Legacy products.

    • Director Regulatory Affairs and Design Assurance North America
      • Feb 2011 - Oct 2011

      Leadership of the Regulatory Affairs and Design Assurance development and strategy for the US.

    • Medical Device
    • 100 - 200 Employee
    • Vice President of Regulatory
      • Dec 2014 - Aug 2015

      Regulatory leader at Vascular Solutions supporting the long-standing and successful strategy of developing, distributing and acquiring clinically unique niche devices for coronary and peripheral vascular percutaneous procedures. Regulatory leader at Vascular Solutions supporting the long-standing and successful strategy of developing, distributing and acquiring clinically unique niche devices for coronary and peripheral vascular percutaneous procedures.

    • Medical Equipment Manufacturing
    • 300 - 400 Employee
    • Manager Regulatory Affairs - Men's Health Emerging Technologies
      • Sep 2008 - Feb 2011

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Specialist
      • Sep 2006 - Sep 2008

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Affairs and Import Compliance Specialist
      • Jul 2000 - Aug 2006

  • CACB
    • Fort Atkinson, WI
    • Quality Manager / Project Manager / Founder
      • Jul 1995 - Jul 2003

Education

  • University of Wisconsin-Whitewater
    Bachelor of Applied Science (B.A.Sc.), Education
    1990 - 1994
  • Johns Hopkins University Advanced Academic Programs
    Master's Regulatory Science
    2021 -
  • Johns Hopkins University Advanced Academic Programs
    Master's degree, Regulatory Science
    2021 -

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