Find your path to Melanie
250 people in our graph share verified history with Melanie — schools, employers, funds. One of them is your warm intro.
EricunlockedMelanie: together at University of Phoenix (2007–2009)
Melanie: together at Endogenex
×3Melanie: together at University of Minnesota
×7Melanie: together at University of Phoenix
About
Melanie Hess is Vice President of Regulatory Affairs, Quality Assurance and Compliance at Endogenex. Her work covers regulatory and compliance strategy, quality systems, and patient advocacy, including regulatory and system strategy implementation across product class types internationally.
Regulatory Affairs Leadership at Endogenex
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In turn, Melanie can intro founders to Endogenex's investors below.
Experience
- EndogenexVice President, Regulatory Affairs, Quality Assurance and Compliancecurrent2025 — present
- EndogenexVP, Regulatory Affairs and Quality Assurance2022 — 2025
- CorRen Medical Inc.Board Membercurrent2024 — present
- Osprey MedicalVP, Regulatory, Compliance and Quality2018 — 2022
- Osprey MedicalVice President Regulatory Affairs and Compliance2015 — 2018Greater Minneapolis-St. Paul Area
- Osprey MedicalSr. Director Regulatory Affairs2014 — 2015Minnetonka, MN
- American Medical SystemsDirector, Regulatory Affairs2011 — 2014Minnetonka, MN
- American Medical SystemsSr. Manager, Regulatory Affairs2009 — 2011
- St. Jude MedicalManager, Regulatory Affairs2008 — 2009
- St. Jude MedicalSr. Regulatory Specialist2006 — 2008
- Smiths MedicalSr. Regulatory and Clinical Affairs Associate2004 — 2006
Skills & more
FDA34ISO 1348526PMA17Medical Devices30Design Control20ISO 1497123Regulatory Affairs38Regulatory Submissions9CAPA7V&V11Clinical Trials14Quality System14
+8 more
GCP21 CFR21 CFR Part 11Clinical DevelopmentBiomedical EngineeringValidationProduct LaunchFDA GMPFrom Melanie's professional profile.
Frequently asked questions
- Who is Melanie Hess?
- Melanie Hess is Vice President of Regulatory Affairs, Quality Assurance and Compliance at Endogenex. Her work covers regulatory and compliance strategy, quality systems, and patient advocacy, including regulatory and system strategy implementation across product class types internationally.
- Where does Melanie Hess work?
- Melanie Hess is Regulatory Affairs Leadership at Endogenex.
- Where did Melanie Hess go to school?
- Melanie Hess studied at University of Minnesota (BSN, Nursing); University of Phoenix (Master of Business Administration (M.B.A.)).
Same school
Also attended University of Minnesota324
Madeline PopeSenior Associate, Platform & Marketing at March Capital PartnersNate LeeFounder and Chief Information Security Officer at Scale Venture PartnersIsaac ZikeManaging Director at RiverVest Venture PartnersDean HlushkoSales Manager (Western U.S.) at Needham FundsRichard HeymanVenture Partner at ARCH Venture PartnersJohn BergstromInvestor at Mairs & Power VC
+ 318 more
Also attended University of Phoenix135
EricAdvisor at Clear VenturesEric SerranoDirector of Technology at GreycroftAndrew ForysiakOwner, AJF and Associates at Riphean InvestmentsMichael JenCCO at K5 GlobalKessington OkundayeVenture Partner at WHCTom DoughertySmarter Technologies at Empactful Capital
+ 129 more
Shared employers
Also worked at Endogenex7
Ms. BakkerManaging Director and Founder at Longitude CapitalGerry BrunkManaging Director at Lumira VenturesJeff TerrellPartner at Arboretum VenturesJuliet BakkerManaging Director at Longitude CapitalTerri BurkeSenior Partner at Intuitive VenturesKrissy WrightChief Financial Officer at Endogenex
+ 1 more
Also worked at Osprey Medical1
Also worked at American Medical Systems1
Also worked at St. Jude Medical36
Barbara BickhamFounder and Managing Partner at Trailyn VCChris JappManaging Partner at Tramway Venture PartnersKyle CoxManaging Partner at ATPNarendra NayakPartner at Deerfield Management CompanyMark WadePartner at CAZ InvestmentsMonica VajaniExecutive Director, mHUB Accelerator at mHUB
+ 30 more