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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