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    James Gianoutsos

    Founder & President at Rimsys Regulatory Management Software

    James Gianoutsos is the Founder and CEO of Rimsys Regulatory Management Software, a company he established in 2017.2 With over 17 years of experience in the regulatory and quality industry, Gianoutsos has a strong background in medical technology and regulatory affairs.3

    Professional Background

    Career Highlights::

    • Started his career at Philips
    • Worked for several small and medium-sized medtech manufacturers
    • Managed global regulatory operations and submissions
    • Handled complex regulatory transitions like EU MDR and IVDR

    Experience with Medical Devices:: Gianoutsos has worked with a wide range of medical technologies, including:

    • CPAP devices
    • Internal surgical adhesives
    • Consumer products like pacifiers
    • Incubators

    Founding of Rimsys

    Gianoutsos founded Rimsys on May 31, 2017, immediately after being laid off from his previous position.3 He recognized a gap in the market for regulatory information management software specifically tailored to the medtech industry, as existing solutions primarily catered to the pharmaceutical sector.3

    Rimsys Regulatory Management Software

    Under Gianoutsos' leadership, Rimsys has developed into a leading provider of Regulatory Information Management (RIM) software for medical technology companies.14 The platform aims to:

    • Digitize and automate regulatory activities
    • Help medtech regulatory affairs teams work more efficiently
    • Accelerate product market entry
    • Ensure global regulatory compliance

    Education and Certifications

    Gianoutsos holds:

    • A Bachelor's Degree in Operations Management from Indiana University of Pennsylvania
    • An MBA in Operations Management and Strategy from the University of Pittsburgh2

    He has also earned several professional certifications, including:

    • Regulatory Affairs Certificate - Medical Devices (RAPS)
    • Certified Six Sigma Green Belt (CSSGB)
    • Certified Quality Auditor (CQA)2

    James Gianoutsos continues to lead Rimsys in its mission to improve global health by accelerating the delivery and increasing the availability of life-changing medical technologies.4

    Highlights

    Aug 12 · rimsys.io
    Insights from the Gens and Associates Executive Podcast ... - Rimsys
    May 6 · businesswire.com
    Rimsys Launches Community-Driven Regulatory Intelligence
    Apr 19 · growjo.com
    Rimsys Regulatory Management Software Revenue and Competitors

    Related Questions

    What inspired James Gianoutsos to create Rimsys?
    How did James Gianoutsos' experience at Philips influence his work at Rimsys?
    What are some key features of Rimsys Regulatory Management Software?
    How has Rimsys evolved since its founding in 2017?
    What challenges did James Gianoutsos face when launching Rimsys?