NJK & Associates, Inc.

Helping you jump your highest regulatory hurdles

Quotables

Natalie

Roger

Norm

Alan

Gabriela

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 became a partner in NJK & Associates in 2007, after a decades long career working in industry.

His industrial experience includes work in R&D, product development, manufacturing, and quality assurance. Along the way he earned over 50 US patents, most for medical devices.

A seasoned teacher, Roger brings a hands-on leadership style to his work, helping your people in understanding what the regulations demand and how to satisfy them in a straightforward manner.

His experience in problem solving and root cause investigation has helped clients to discover and fix issues, often before they became customer problems or reportable events.

He has helped clients with all aspects of medical device and IVD projects, from product development to manufacturing, from creating to maintaining a culture of compliance. He provides valuable insights to your management team by performing internal, due diligence, and supplier audits.

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.

Alan Baumel

Alan is a Quality and Regulatory professional with experience working at both startup and established companies.

He has extensive industry experience, working for both large corporations and startups, in Reliability Engineering, Quality Assurance, Operations, and Regulatory Affairs.

Alan expands upon the NJK skill set with specific experience including semiconductor manufacturing, implantable defibrillators, cardiac ablation systems, and cardiac monitoring.

His corporate experience includes Medtronic, W. L. Gore & Associates, and Cameron Health (now Boston Scientific).

Alan holds a BA from the University of Oklahoma and is an ASQ Certified Reliability Engineer.

Gabriela McCoole, ASQ CQA

Gabriela joined NJK & Associates in 2017. She holds an MS degree in molecular biology from UCLA, and is proficient in clinical laboratory management, internal auditing, gap assessments, and preparation and support of regulatory inspections.

She is additionally skilled at implementation and improvement of  quality systems, and provides creative problem solving.

Visit her LinkedIn profile to learn more.

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