Marcella Garcia
InvestorEntrepreneur-in-Residence at BioHealth Innovation, Inc. · Business Support Manager at Aream & Co.
Greater Boston
Find your path to Marcella
231 people in our graph share verified history with Marcella — schools, employers, funds. One of them is your warm intro.
Payton DobbsunlockedMarcella: together at Vanderbilt University (1997–2000)
×7Marcella: together at Dell
×4Marcella: together at Vanderbilt University
About
Marcella Garcia is a regulatory, quality, and compliance professional focused on medical devices, Software as a Medical Device (SaMD), and digital health technologies. She works as a Principal Consultant advising early-stage startups globally on regulatory pathways and quality management systems. She holds a B.S. in Electrical and Computer Engineering from Vanderbilt University and certifications including HCISPP from (ISC)², Certified SAFe Agile Scrum Master, and Cybersecurity for Managers from MIT Professional Education.
Invests in
Digital HealthMedical Devices
Experience
- BioHealth Innovation, Inc.EIR - Regulatory, Quality, and Cybersecuritycurrent2025 — presentBoston, Massachusetts, United States
- Mansfield Bio-IncubatorMentor - Regulatory, Quality, and Information Securitycurrent2025 — presentMansfield, Massachusetts, United States
- Massachusetts Innovation NetworkMentor & Judge - Regulatory, Quality, and Information Securitycurrent2024 — presentBurlington, Massachusetts, United States
- Self EmployedFractional Consulting - Regulatory Affairs, Quality Assurance, Information Security - SaMD AI/MLcurrent2018 — presentBoston, Massachusetts, United States
- Microhealth (digital hematology)VP Regulatory Affairs, Quality Assurance, and Information Security2024 — 2025Boston, MA
- Nia TherapeuticsVP Regulatory Affairs and Quality Assurance - Neurostimulation / Active Implantables2022 — 2023Boston, Massachusetts, United States
- Health Data Analytics InstituteSr. Director of Quality and Compliance - Predictive Analytics Population Health2021 — 2022Dedham, Massachusetts, United States
- Happify HealthDirector of Quality and Compliance - Digital Therapeutics2019 — 2021Greater Boston Area
- Pyramid Technical Consultants, Inc.Sr. Director - Regulatory, Quality & Risk Management - Proton Therapy for Cancer Treatment2012 — 2018Lexington, MA
- DellSr. Product Engineering Manager / Supplier Quality Engineering Manager - Liquid Crystal Displays2001 — 2007Austin, TX
Skills & more
External Audits1Risk Management1Information Security9Artificial Intelligence (AI)7Medical Devices1Regulatory Submissions1Cross-functional Team Leadership4Business Process Improvement3Regulatory Affairs1Quality ManagementStrategic Planning9Strategy2
- Certified SAFe® Scrum Master — SAFe by Scaled Agile, Inc.
- Venture Institute - Cohort 2 - 2023 — VC Lab
- CRA - Interim Monitoring Visits — CITI Program
- Privacy and Security for Healthcare Organizations — ISC2
- Healthcare Essentials: Information Security in Healthcare Settings — ISC2
- Risk Management and Risk Assessment in a Healthcare Setting — ISC2
- HCISPP — ISC2
- Cyber Risk Management — MIT Professional Education
- ISO 13485 Lead Auditor - Certification — BSI
From Marcella's professional profile.
Colleagues at BioHealth Innovation, Inc.
Albine Martin
Entrepreneur-in-Residence at BioHealth Innovation, Inc.
Charles Buchen
Entrepreneur-in-Residence at BioHealth Innovation, Inc.
Chris Chen
Executive Vice President of Mission-Aligned Investments at Arnold Ventures
Diane Ignar
Entrepreneur-in-Residence at BioHealth Innovation, Inc.
Douglas Liu
Entrepreneur-in-Residence at BioHealth Innovation, Inc.
Jemarie Haskin
Finance, Operations and HR at BioHealth Innovation, Inc.
Jennifer Butler
Entrepreneur-in-Residence at BioHealth Innovation, Inc.
Jessica E. Foley
Entrepreneur-in-Residence at BioHealth Innovation, Inc.
Frequently asked questions
- Who is Marcella Garcia?
- Marcella Garcia is a regulatory, quality, and compliance professional focused on medical devices, Software as a Medical Device (SaMD), and digital health technologies. She works as a Principal Consultant advising early-stage startups globally on regulatory pathways and quality management systems. She holds a B.S. in Electrical and Computer Engineering from Vanderbilt University and certifications including HCISPP from (ISC)², Certified SAFe Agile Scrum Master, and Cybersecurity for Managers from MIT Professional Education.
- Where does Marcella Garcia work?
- Marcella Garcia is Entrepreneur-in-Residence at BioHealth Innovation, Inc..
- What does Marcella Garcia invest in?
- Marcella Garcia invests in Digital Health, Medical Devices.
- Where did Marcella Garcia go to school?
- Marcella Garcia studied at Vanderbilt University (Engineering, Computer Engineering).
Same school
Also attended Vanderbilt University374
Jacob JofeInvestor at Index VenturesRoss Perot Jr.Chairman of The Perot Group at Perot JainDavid JohnsonManaging Director at Intel Capital, North AmericaTom DriscollPrincipal at Differential VenturesSabina SmithPrincipal at Scale Venture PartnersPayton DobbsOperating Partner at Hoxton Ventures
+ 368 more
