Natalie J. Kennel, RAC, ASQ CQE & CQMgr
Natalie founded NJK & Associates, a medical device consultancy, to bring her practical perspective to medical device quality and regulatory affairs.
With more than 25 years in industry She has hands-on experience with development, manufacturing and Regulatory Affairs/Quality Assurance (RA/QA) as well as having served in clinical roles in both major and start up medical device companies.
Since forming NJK & Associates in 2005 she has submitted more than thirty 510(k)’s and numerous Pre-Submissions, set up quality systems for client companies, and provided on-going RA/QA services. She has prepared numerous international medical device submissions for Australia, Europe, Canada, and Singapore. She set up quality systems and currently provides regulatory affairs support for a novel tissue bank.
Natalie has been published in RAPS regarding clinical trials for medical devices. She has spoken at several industry organization conferences including SDRAN, ASQ and ACRP on multiple regulatory, quality and clinical topics. She is past president of SDRAN.
For the past 12 years she has taught the medical device submission section for the U.S. RAC study group, and regularly teaches a software validation seminar for the USC regulatory affairs master’s program.
Natalie holds a BS degree in Chemical Engineering from the University of Rochester.