Natalie J Kennel

Natalie Kennel is a senior quality and regulatory affairs professional with over 25 years experience in medical device and other high tech manufacturing industries. Her experience with medical devices spans across a number of markets including orthopedics, surgical instruments, electro-mechanical devices, infusion pumps, blood glucose monitors, orbital implants, intraocular lenses and medical device software. In the area of diagnostics, Natalie has worked with both in-vitro diagnostics and molecular diagnostics along with pharmacogenetics. As a consultant, Natalie has prepared or supported more than thirty 510(k) submissions, more than 20 pre-submissions and supplements and developed product test plans to support regulatory submissions. She has designed and implemented Quality Systems compliant to FDA QRS & ISO 13485, MDD, IVDD, and Canadian Medical Device Regulations. In addition, Natalie has developed quality and GCP training programs, and conducted software validation strategies. She has also written clinical study protocols and IDE final reports.

Prior to consulting, Natalie was at number of companies with increasing responsibility (J&J Ortho-Clinical Diagnostics, LSI Solutions, Alaris Medical Systems, PLUS Orthopedics, and Eastman Kodak).

Natalie holds a BS in Chemical Engineering from the University of Rochester. In 2001, she received her Regulatory Affairs Certification (RAC) and has been ASQ certified since 1999.