Melanie Hess Email & Phone Number
Vice President, Regulatory Affairs, Quality Assurance and Compliance @ Endogenex
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Melanie Hess Location
- United States
Melanie Hess Work
- Vice President, Regulatory Affairs, Quality Assurance and Compliance @ (January 2025 - Present)
- VP, Regulatory Affairs and Quality Assurance @ (May 2022 - January 2025)
- Board Member @ (October 2024 - Present)
- VP, Regulatory, Compliance and Quality @ (August 2018 - May 2022)
- Vice President Regulatory Affairs and Compliance @ (March 2015 - August 2018)
- Sr. Director Regulatory Affairs @ (March 2014 - March 2015)
- Director, Regulatory Affairs @ (May 2011 - March 2014)
- Sr. Manager, Regulatory Affairs @ (July 2009 - May 2011)
- Manager, Regulatory Affairs @ (July 2008 - July 2009)
- Sr. Regulatory Specialist @ (December 2006 - July 2008)
- Sr. Regulatory and Clinical Affairs Associate @ (December 2004 - January 2006)
Melanie Hess Education
- University of Phoenix
Master of Business Administration (M.B.A.)
2005-2009 - University of Minnesota
BSN (Nursing)
1991-1996
Melanie Hess Skills
- FDA
- ISO 13485
- PMA
- Medical Devices
- Design Control
- ISO 14971
- Regulatory Affairs
- Regulatory Submissions
- CAPA
- V&V
- Clinical Trials
- Quality System
- GCP
- 21 CFR
- 21 CFR Part 11
- Clinical Development
- Biomedical Engineering
- Validation
- Product Launch
- FDA GMP
- Premarket Approval (PMA)
- Regulatory
- Premarket Approval Pma
- Premarket Approval
Melanie Hess Summary
- Melanie Hess, based in United States, is currently a Vice President, Regulatory Affairs, Quality Assurance and Compliance at Endogenex. Melanie Hess brings experience from previous roles at Endogenex, CorRen Medical Inc. and Osprey Medical. Melanie Hess holds a 2005 - 2009 Master of Business Administration (M.B.A.) @ University of Phoenix. With a robust skill set that includes FDA, ISO 13485, PMA, Medical Devices, Design Control and more. Melanie Hess has 2 emails and 3 mobile phone numbers on RocketReach.
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Top Endogenex Employees
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Daniel Shertok
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Christopher Sorli
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Brittany Haislet
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Matt Cambronne
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Alex McLean
Principal Manufacturing Engineer
Hopkins, MN, US
Evelyn Rodríguez Gómez
Quality Manager
United States
Emily do
Field Clinical Specialist
Austin, TX, US
Ben Haselman
Principal R and D Engineer
Saint Paul, MN, US
Brent Collins
Vice President of Market Development
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Chris Deegan
Director of Program Management
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Lori Herman
Sr. Field Clinical Specialist
Saint Paul, MN, US
John Pocrnich
Principal R and D Technician
Saint Paul, MN, US
Zackary Becker
R and D
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Krissy Wright
Chief Financial Officer
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Stacey Pugh
Chief Executive Officer
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Emily E.
Controller
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