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
- 2025 -now Vice President, Regulatory Affairs, Quality Assurance and Compliance @
- 2022 -2025 VP, Regulatory Affairs and Quality Assurance @
- 2024 -now Board Member @
- 2018 -2022 VP, Regulatory, Compliance and Quality @
- 2015 -2018 Vice President Regulatory Affairs and Compliance @
- 2014 -2015 Sr. Director Regulatory Affairs @
- 2011 -2014 Director, Regulatory Affairs @
- 2009 -2011 Sr. Manager, Regulatory Affairs @
- 2008 -2009 Manager, Regulatory Affairs @
- 2006 -2008 Sr. Regulatory Specialist @
- 2004 -2006 Sr. Regulatory and Clinical Affairs Associate @
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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