Matthew Rycyk, M.S., RAC
CMC / Quality Subject Matter Expert (SME)
Matthew Rycyk is a 15 year + veteran of the biomedical field. In 2001 he graduated from the University of Illinois Champaign with a BS in Animal Sciences. His early career consisded of medical research at Northwestern Medical School in downtown Chicago where he studied in the Department of Urology under Dr. Anthony Schaeffer and Dr. David Klumpp. He then went on to continue researching new active small molecule drugs for the pharmaceutical industry focusing on animal models.
In 2010 he was part of the first graduating class of the new Biomedical and Pharmaceutical Regulatory Affairs program at the University of Georgia. In 2011 he became RAPS regulatory affairs certified in the United States. He has worked for medical device companies (CFR 820 and ISO 13485) Pharmaceutical Companies, Biological Drug companies and dietary supplement manufactring organizations working in both quality and regulatory for the past 8 years. Some career highlights include creation of a ISO 13485 QMS from the ground up for a class 2-b implantable product, various NDA applications, the approval of a sBLA for an 80,000 sq foot, numerous inspections with FDA investigators (CDHR, CDER, Team Biologics, CFSAN, OCI) with little or no observations, and a 3 year proven history of 20+ consulting clients for small and medium sized organizations.