Angela Johnson
Professor of Strategic Development and Regulatory Affairs - Biotech and Medtech @Northeastern University College Of Professional Studies
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WORK HISTORY
Professor of Strategic Development and Regulatory Affairs - Biotech and Medtech @Northeastern University College Of Professional Studies
Boston, MA, US
EDUCATION
Texas Tech University
Doctor of Philosophy (PhD), Technical Communication, Rhetoric of Science & Healthcare
The Johns Hopkins University
Certificate, Design of Clinical Trials
University of North Carolina Wilmington
Post-Grad, Premedical Studies
North Carolina State University
Masters of Science & Engineering (MSE), Materials Engineering
East Carolina University
Bachelor, FA & Communications
SKILLS
ABOUT ANGELA JOHNSON
I’m a senior executive specializing in R&D, clinical trial design, regulatory strategy, and commerical market access for novel therapeutics, medical devices, and cell and gene therapy. My career spans 25+ years across medical device and diagnostics, biotech, health tech, and global clinical services, leading cross-functional teams from startup to Fortune 500 scale.I’ve built and scaled global medtech organizations, led compliance and diligence activities for buy- and sell-side M&A in medtech/biotech, led successful regulatory FDA 510(k), BLA, NDA, and EMA submissions, and driven compliance strategy aligned with ISO 13485, ICH/ISO-GCP, and Title 21 CFR Part 11. I’m passionate about ethical innovation, patient access, and mentoring the next generation of life science leaders.I also contribute to academic and research initiatives in digital health and AI ethics, particularly through TRC Labs—a collaborative project designing morally and culturally aligned AI tools for clinical, regulatory, and education spaces.Whether navigating EU MDR/IVDR transitions, designing global trial strategies, or mentoring founders, my approach blends precision, empathy, and scale. I believe innovation should be both regulatory-ready and human-centered.
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