Last Update

2016-05-04T00:00:00.000Z

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Wrong Natalie Kennel?

Natalie J. Kennel

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Background Information

Employment History

Acrobat PDF

President

NJK & Associates Inc

Director of Quality, Regulatory and Clinical

Plus Orthopedics

Senior Manager QE

ALARIS Medical Systems , Inc.

Education

Bachelor of Science degree

Chemical Engineering

University of Rochester

Web References (37 Total References)


Natalie J. Kennel, RAC, ASQ ...

njkconsulting.com [cached]

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.


Natalie J. Kennel, RAC, ASQ ...

www.njkconsulting.com [cached]

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.


Natalie J. Kennel, RAC, ASQ ...

www.njkconsulting.com [cached]

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.


Natalie J. Kennel, RAC, ASQ ...

njkconsulting.com [cached]

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.


HOME | NJK & Associates

www.njkconsulting.com [cached]

NJK & Associates was founded in 2006 when Natalie Kennel, RAC, ASQ CQE & CQMgr recognized an unmet need in the medical device community: QA/RA help from industry experts willing to get their hands dirty.

Her years of experience in industry as well as her lifelong pursuit of learning led to the realization that the way much of industry was approaching QA/RA was by growing systems with ever increasing complexity. She recognized that unnecessary complexity leads to employees finding ways to work-around the systems and to lacks of conformance both to the systems and the regulations. Her better way was the creation of our first, from-scratch quality system.
...
NJK & Associates, Inc. was founded by Natalie J. Kennel, RAC, ASQ CQE & CQMgr who serves as its president. Prior to her consulting career she worked for companies designing and manufacturing IVDs, surgical devices, and infusion pumps. Natalie has held a variety of roles in quality, regulatory, development, and manufacturing in both large and small companies. Natalie is expert in the development of new quality systems, software validation, and companies with regulatory agency "issues".

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