Sarah Pleaugh

Associate Director Regulatory Affairs at MCRA
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Contact Information
us****@****om
(386) 825-5501
Location
US

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Credentials

  • Regulatory Affairs Professional Society
    Regulatory Affairs Professionals Society (RAPS)
    Dec, 2015
    - Nov, 2024

Experience

  • MCRA
    • United States
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Associate Director Regulatory Affairs
      • Nov 2021 - Present

  • Philips
    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Affairs Manager
      • Sep 2021 - Nov 2021

    • Regulatory Affairs Specialist
      • Sep 2020 - Sep 2021

  • RTI Surgical®
    • United States
    • Medical Equipment Manufacturing
    • 200 - 300 Employee
    • Regulatory Affairs Manager
      • Mar 2020 - Sep 2020

    • System Engineer
      • Feb 2019 - Mar 2020

    • Regulatory Affairs Sr. Specialist
      • May 2010 - Feb 2019

      -Prepare USA 510(k) submissions and International product registration submissions. Ensure that existing approvals and documentation are maintained.-Provide regulatory review of labeling, promotional literature, DVe protocols, and Design History File documentation.-Interface directly with engineering and marketing teams during product development to understand products and submission details-Interface directly with international distributors and regulatory agencies to complete international product registrations-Disseminate large amounts of technical and marketing information into clear and concise reports and submissions Show less

  • Pioneer Surgical Technology
    • Test Engineer
      • Jun 2007 - May 2010

Education

  • Michigan Technological University
    B.S. Biomedical Engineering, Biomedical/Medical Engineering
    2007 - 2009
  • Milwaukee School of Engineering
    Biomedical Engineering, Biomedical/Medical Engineering
    2006 - 2007

Community

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