Andre Leak, Director, Regulatory Affairs and Quality Assurance at Spaulding Medical

Andre Leak

Director, Regulatory Affairs and Quality Assurance at Spaulding Medical | Jackson, Wisconsin, Belarus

Profile last verified August 2026
Medical Devices Verified Profile Jackson, Wisconsin, Belarus University of Wisconsin-Milwaukee
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Personal Email

***@hotmail.com

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Phone Number

(414) ***-*413

Belarus • Phone

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Andre Leak Socials
Andre Leak Work Experience

Director, Regulatory Affairs and Quality Assurance at Spaulding Medical in June 2020 - Present

Regulatory Affairs Coordinator at American Orthodontics in March 2018 - June 2020

FDA Compliance Manager at Nemschoff in March 2016 - March 2018

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Manager of Regulatory Affairs at Spaulding Clinical Research, LLC in June 2013 - March 2016

Regulatory Affairs Analyst at Life Technologies in December 2009 - May 2013

Compliance Specialist - Quality Assurance at Unilever in January 2006 - January 2008

Chemical Operator - Small Scale Production at Sigma Aldrich in January 2005 - January 2006

Andre Leak Education

University of Wisconsin-Milwaukee, Bachelor's

Andre Leak Skills
o Product Commercialization Process (PCP) o Software Development Life Cycle (SDLC) o Risk Management Intensive Training - ISO 14971:2007 o Investigations & Tools for getting to Root Cause o Design Control o Changes and the 510(k) o Statistics and Statistical Control Intensive Project Planning o Medical Device approval process and compliance in Japan, Brazil, India, Egypt o System Auditor Training for ISO 13485, CFR 820, CMDR Life Science Industry CAPA GMP FDA Quality System SOP Regulatory Submissions Medical Devices HACCP Regulatory Audits Regulatory Affairs Certification FDA - Medical Device Data systems IEC 60601-1 IEC 60601-2-25 IEC 60601-1-11 AAMI / ANSI EC53 IEC 60601-2 IEC 60601-2-51 IEC 60601-1-6 IEC 60529 Biotechnology Change Control IEC 60601 ISO 13485 Life Sciences Pharmaceutical Industry Quality Assurance Regulatory Affairs Sop Validation
About Andre Leak’s Current Company
Spaulding Medical

Maker of the 12-lead Spaulding Electrocardiograph and webECG software, an innovative medical device which streams ECGs to Android, Apple iOS and Windows and stores them in the cloud.

Discover more about Spaulding Medical
Andre Leak’s Colleagues
Anna Strupp

Anna Strupp

West Bend, Wisconsin, United States

Looking for work in Washington County

Promotions Specialist at Potawatomi Hotel & Casino
(March 2003 – Present)

Brad Johansen

Brad Johansen

Milwaukee, Wisconsin, United States

Business Development Manager at Spaulding Medical

Project Manager at Spaulding Medical
(April 2021 – Present)

Allison Newman

Allison Newman

Greater Milwaukee

COA

Clinical Operations Associate at Spaulding Medical
(March 2022 – Present)

Alissa Fischer

Alissa Fischer

Plymouth Town, Wisconsin, United States

--

Project Manager at Spaulding Medical
(July 2021 – Present)

Amanda Baltz

Amanda Baltz

Milwaukee, Wisconsin, United States

CEO at Spaulding Medical

Medical device and software company.

Renee L

Renee L

Saint Johns, Florida, United States

IT Systems Administrator/Product Development Engineer/Project Manager

Systems Administrator at Spaulding Medical
(Sep 2024 – Present)

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Frequently asked questions about Andre Leak

What is Andre Leak email address?

Email Andre Leak at [email protected] and [email protected]. This email is the most updated Andre Leak's email found in 2026.

How to contact Andre Leak?

To contact Andre Leak send an email to [email protected] or [email protected].

What company does Andre Leak work for?

Andre Leak works for Spaulding Medical.

What is Andre Leak's role at Spaulding Medical?

Andre Leak is Director, Regulatory Affairs and Quality Assurance

What industry does Andre Leak work in?

Andre Leak works in the Medical Devices industry.

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