NJK & Associates, Inc.

Helping you jump your highest regulatory hurdles

Quotables

Natalie

Roger

Norm

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.

Roger Greenwald

Roger is a prolific inventor and problem solver with 49 US patents, most for medical devices. He has extensive industry experience, working for both giant corporations, startups, and those in-between in R&D, product development, manufacturing, and quality assurance roles. In 2007 he became a partner in NJK & Associates, Inc.

Roger helps clients with everything from product development and improvement to manufacturing, and has significant experience qualifying and improving vendor compliance worldwide. His broad experience is also utilized in due-diligence audits when clients are considering acquisitions.

His corporate experience includes Eastman Kodak and Alaris Medical Systems (now Carefusion).

Roger holds a BS in physics from Northeastern University and an MS in optics from the University of Rochester.

Visit his LinkedIn profile to learn more.

Norm Hutton

Norm is a seasoned manufacturing engineer with worldwide contacts.

He  developed his skills and industry contacts over 26 years working at Becton Dickinson where he managed the sustaining engineering function in the diagnostics division, preanalytical systems and at Chesbrough-Ponds as production supervisor in the high speed filling/molding department.

 

Norm holds a BS in mechanical engineering from Syracuse University. He is Design for Six Sigma certified and is expert in PET injection molding and co-injection molding among other things.

Norm was awarded 4 US patents and received numerous awards while at BD.

When it comes to choosing and working with your contract or in-house manufacturers Norm is the go to guy.

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