Let’s face it - regulatory affairs is a critical business function for regulated industries that is a misunderstood, highly complex, and ever-evolving profession.
Regulatory costs are rising, regulatory burdens are increasing, global regulatory matters are becoming more complex, and qualified candidates are scarce.
The mismanagement of information can cost your company time, money and resources.
In this free 60-minute webinar, our presenter, James W. Gianoutsos, Director of QA/RA at Carmell Therapeutics, Founder of RIMSYS Regulatory Software, and Principal Consultant at Regality Consulting, LLC discusses the current regulatory intelligence landscape and how to properly manage information from a practical and innovative software solutions standpoint.
Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
James W. Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industry. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices.
James has worked comprehensively with products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants.
James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) from the University of Pittsburgh.
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS,
Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.
Regality Consulting is a client-focused consulting service specially tailored to meet the needs of the medical device market. We are here to improve regulatory compliance, increase quality awareness, and expedite time-to-market. Click here to learn more.