Adrienne Lenz
Principal Medical Device Regulation Expert at Hyman, Phelps & McNamara, P.C.- Claim this Profile
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Bio
Tammy Noll
I am pleased to be writing this recommendation for Adrienne Lenz. I worked with Adrienne for three years at GE Healthcare. In my opinion, Adrienne is an experienced business leader capable of understanding global complex information to determine an optimal solution with the best return on investment. This business knowledge works perfectly with her expertise in regulatory. Adrienne's expertise provides solid regulatory guidance for many different global business situations. I highly recommend Adrienne to provide regulatory leadership and guidance.
Laurence Yudkovitch
Adrienne joined our team with outstanding references and exceeded our expectations. She grasped the complexities of our product quickly and lead us through multiple regulatory submissions and clinical trials. She provided us with clear, concise advice and worked with us to customize the strategy for our situation. Adrienne is a pleasure to work with and was a great asset to our organization. I would highly recommend her!
Tammy Noll
I am pleased to be writing this recommendation for Adrienne Lenz. I worked with Adrienne for three years at GE Healthcare. In my opinion, Adrienne is an experienced business leader capable of understanding global complex information to determine an optimal solution with the best return on investment. This business knowledge works perfectly with her expertise in regulatory. Adrienne's expertise provides solid regulatory guidance for many different global business situations. I highly recommend Adrienne to provide regulatory leadership and guidance.
Laurence Yudkovitch
Adrienne joined our team with outstanding references and exceeded our expectations. She grasped the complexities of our product quickly and lead us through multiple regulatory submissions and clinical trials. She provided us with clear, concise advice and worked with us to customize the strategy for our situation. Adrienne is a pleasure to work with and was a great asset to our organization. I would highly recommend her!
Tammy Noll
I am pleased to be writing this recommendation for Adrienne Lenz. I worked with Adrienne for three years at GE Healthcare. In my opinion, Adrienne is an experienced business leader capable of understanding global complex information to determine an optimal solution with the best return on investment. This business knowledge works perfectly with her expertise in regulatory. Adrienne's expertise provides solid regulatory guidance for many different global business situations. I highly recommend Adrienne to provide regulatory leadership and guidance.
Laurence Yudkovitch
Adrienne joined our team with outstanding references and exceeded our expectations. She grasped the complexities of our product quickly and lead us through multiple regulatory submissions and clinical trials. She provided us with clear, concise advice and worked with us to customize the strategy for our situation. Adrienne is a pleasure to work with and was a great asset to our organization. I would highly recommend her!
Tammy Noll
I am pleased to be writing this recommendation for Adrienne Lenz. I worked with Adrienne for three years at GE Healthcare. In my opinion, Adrienne is an experienced business leader capable of understanding global complex information to determine an optimal solution with the best return on investment. This business knowledge works perfectly with her expertise in regulatory. Adrienne's expertise provides solid regulatory guidance for many different global business situations. I highly recommend Adrienne to provide regulatory leadership and guidance.
Laurence Yudkovitch
Adrienne joined our team with outstanding references and exceeded our expectations. She grasped the complexities of our product quickly and lead us through multiple regulatory submissions and clinical trials. She provided us with clear, concise advice and worked with us to customize the strategy for our situation. Adrienne is a pleasure to work with and was a great asset to our organization. I would highly recommend her!
Credentials
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RAC-US
REGULATORY AFFAIRS CERTIFICATION PROGRAMDec, 2007- Nov, 2024
Experience
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Hyman, Phelps & McNamara, P.C.
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United States
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Law Practice
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1 - 100 Employee
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Principal Medical Device Regulation Expert
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Jan 2022 - Present
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Senior Medical Device Regulation Expert
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Sep 2017 - Jan 2022
http://hpm.com/professionals/2957-2/
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Emergo by UL
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Senior Consultant, QA & RA
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Oct 2010 - Aug 2017
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Pathway Regulatory Consulting, LLC
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Medical Equipment Manufacturing
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Member
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Jun 2010 - Aug 2017
Pathway Regulatory Consulting, LLC is a consulting company founded in Waukesha, Wisconsin, USA in 2010. Our goal is to help medical devices manufacturers obtain market authorizations to sell products in the United States, European Union and Canada. We provide a wide range of services from Regulatory strategy and submission to Quality Management System support. Pathway Regulatory Consulting, LLC is a consulting company founded in Waukesha, Wisconsin, USA in 2010. Our goal is to help medical devices manufacturers obtain market authorizations to sell products in the United States, European Union and Canada. We provide a wide range of services from Regulatory strategy and submission to Quality Management System support.
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GE HealthCare
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United States
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Hospitals and Health Care
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700 & Above Employee
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Regulatory Affairs Director
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Mar 2009 - Jul 2010
Led premarket regulatory affairs for global Life Support Solutions business, which includes Anesthesia, Respiratory Care and Maternal-Infant Care products and a team with employees in the US, Europe and Asia.
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Regulatory Affairs Manager
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Jul 2008 - Feb 2009
Led team supporting pre- and post-market regulatory affairs for anesthesia and ventilator products.
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Sr. Regulatory Affairs Specialist
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Feb 2007 - Jul 2008
Regulatory Affairs for Anesthesia and Respiratory Care devices.
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Sr. Quality Engineer
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Jul 2004 - Feb 2007
Quality Engineer for Diagnostic Cardiology Devices.
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Smiths Medical
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United States
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Medical Equipment Manufacturing
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500 - 600 Employee
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Regulatory Engineer
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Nov 1997 - Jul 2004
Regulatory Affairs for Patient Monitoring devices.Quality Systems.Clinical Trials.Medical Device Standards. Regulatory Affairs for Patient Monitoring devices.Quality Systems.Clinical Trials.Medical Device Standards.
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Education
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1995 - 1998
Medical College of Wisconsin
MS, Physiology -
1991 - 1995
Milwaukee School of Engineering
BS, Biomedical Engineering
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