Joel Kent

Lecturer

About

Joel Kent, MSc. RAC, FRAPS is currently Senior Manager, Regulatory Affairs for GE Healthcare, Clinical Care Solutions business. He has 26 years of experience in regulatory affairs covering a variety of medical devices. He holds a Bachelor of Science degree in Electrical and Biomedical Engineering from Duke University and a Master of Science in Biomedical Engineering from Worcester Polytechnic Institute.

Mr. Kent has nine publications related to pulse oximetry and gastric tonometry and has been granted two US and Japanese patents for remote sensing tonometric catheter apparatus and method. He is a senior lecturer at Northeastern University in Boston, MA and a lecturer at Regis College in Weston, MA as well as an IEEE Senior Member and American Society for Quality (ASQ) Senior member. In addition Mr. Kent is a Regulatory Affairs Professional Society Fellow (FRAPS), holds the RAC (CAN, EU and US) and is serving as Vice-Chair of the RAPS Boston Chapter. He served on the RAPS Medical Devices Expert Advisory Group, RAPS 2008-2011, the 2016 Annual Conference Committee and the RAPS Annual Conference's  Pre-conference workshop committee on Latin America Medical Device Regulations in 2012 and 2013.  Mr. Kent was also a member of the advisory council for the mHealth Regulatory Coalition.  Speaking engagements have included the RAPS Annual Conferences, local RAPS Chapter meetings, Medical Devices Summit East 2011-2014 and 2018, 11th annual AdvaMed Emerging Growth Company Council conference, BIOMEDevice Boston 2013 and the MassMEDIC's “The EU Medical Device Regulation (MDR): Implementing Changes - June 19, 2018.” He has been an instructor in Regulatory Affairs since 2008.

Education

Master of Science from Worcester Polytechnic Institute (1988)

Professional Experience


 Global Regulatory Affairs Strategy
 100+ 510(k) Submissions
 Adjunct Professor Regulatory Affairs and Bioengineering
 Intellectual Property Coordination
 Patented Automated System
 Liaison to Contract Manufacturer
 Manager of R&D Laboratory
 Quality System auditor
 Clinical Evaluation of New Products