Lisa Baumhardt Email & Phone Number
Senior Director Regulatory Affairs @ CovarsaDx
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Lisa Baumhardt Location
- Menomonee Falls, WI, US
Lisa Baumhardt Work
- Senior Director Regulatory Affairs @ (July 2026 - Present)
- Principal Medical Device Regulatory Expert @ (January 2025 - July 2026)
- Senior Medical Device Regulation Expert @ (September 2021 - August 2025)
- Regulatory Affairs, Senior Manager @ (April 2021 - September 2021)
- RAQA Executive, R and D Quality @ IBM Watson Health Imaging (October 2020 - April 2021)
- Sr. Manager of Global Regulatory Affairs AI Strategy @ IBM Watson Health Imaging (July 2019 - October 2020)
- Sr. Regulatory Affairs Compliance Program Manager @ (September 2017 - October 2020)
- Associate Director Global Regulatory Affairs - Combination Product and Devices @ (May 2016 - August 2017)
- Regulatory Affairs Director @ (February 2013 - June 2016)
- Sr. Regulatory Compliance Manager, Legal @ (August 2010 - February 2013)
- Corporate Regulatory Affairs Manager - PreMarket Submissions @ (June 2008 - August 2010)
- Regulatory Affairs Program Manager @ (February 2006 - June 2008)
- Regulatory Affairs Manager @ (October 2004 - January 2006)
- Regulatory Affairs Specialist @ (January 2004 - October 2004)
- Product Quality and Clinical Research @ (January 1992 - January 2002)
- Customer Support Specialist @ (January 1992 - January 1993)
Lisa Baumhardt Education
- Loyola University Chicago
Master of Jurisprudence (Health Law)
2011-2013 - Medical College of Wisconsin
M.S. (Healthcare Technology Management)
2004-2008 - Marquette University
B.S. (Medical Technology)
1983-1987
Lisa Baumhardt Skills
- 510(k)
- CAPA
- CE Marking
- CIA Analysis
- Cancer
- Cardiac
- Clinical Research
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Design Control
- EU Medical Device Directive
- FDA
- Federal Regulations
- GMP
- Hardware Diagnostics
- Healthcare
- Hospitals
- ISO 13485
- MRI
- Patient Monitoring
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Reporting
- Regulatory Strategy
- Regulatory Submissions
- Strategy
- Development
- Quality Assurance
- Legal Research
- Customer Service
- 510k
- Legal Writing
- Strategic Planning
- Regulatory
- Leadership
- Medical Devices
- Corrective and Preventive Action Capa
- Cross Functional Team Leadership
- Corrective and Preventive Action
Lisa Baumhardt Summary
- Lisa Baumhardt, based in Menomonee Falls, WI, US, is currently a Senior Director Regulatory Affairs at CovarsaDx. Lisa Baumhardt brings experience from previous roles at Hyman, Phelps & McNamara, P.C., Danaher Corporation and IBM Watson Health Imaging. Lisa Baumhardt holds a 2011 - 2013 Master of Jurisprudence in Health Law @ Loyola University Chicago. With a robust skill set that includes 510(k), CAPA, CE Marking, CIA Analysis, Cancer and more. Lisa Baumhardt has 2 emails and 4 mobile phone numbers on RocketReach.
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Lisa Baumhardt
Senior Director Regulatory Affairs
Menomonee Falls, WI, US
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Annette Murdock-Tangye
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