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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?
James Gianoutsos
James Gianoutsos, photo 1
James Gianoutsos, photo 2
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Location

Greater Pittsburgh Region