Fundraising Fox
Marcella Garcia
InvestorEntrepreneur-in-Residence at BioHealth Innovation, Inc. · Business Support Manager at Aream & Co.
Greater Boston
Find your path to Marcella
268 people in our graph can introduce you to Marcella.
Each arrow is one introduction. Sign up to fill in the first one.
Ask Chris Chen to introduce you to Marcella
You →Chris · together at BioHealth Innovation, Inc. (2025–2026) →Marcella
Ask Jamie Chen to introduce you to Marcella
You →Jamie · 5 people · together at BioHealth Innovation, Inc. →Marcella
Ask Sam Okafor to introduce you to Marcella
You →Sam · 6 people · together at Aream & Co. →Marcella
Sign up to find every way you can get introduced to Marcella
- Your email: the people you already email who know Marcella
- 2nd- and 3rd-degree connections: people you know who worked, studied or invested with Marcella
- Your LinkedIn: the connections who can make the intro for you
We rank every route by how warm it is, so you raise on warm intros instead of cold emails.
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
- 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.
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 University470
+ 464 more
