Dr. Trymore Magomana, MBA. DrPH • MBA • RAC-Devices®
I am a global regulatory affairs executive with over a decade of life-sciences experience directing medical-device strategy, compliance governance, and multi-market access across the U.S., EU, UK, LATAM, and APAC. Trained as a public-health scientist and systems thinker, I integrate regulatory rigor, health-policy insight, and responsible leadership to stabilize organizations, accelerate innovation, and strengthen patient outcomes worldwide.
Latest Insights
I write about regulatory governance and the systems that enable safe medical-device innovation across global markets. With training in sub-Saharan African public health systems, I also explore health policy, implementation, and institutional capacity-building across the region.
Academic Publications & Thesis
Creative Works (Novels)
Professional Profile
Dr. Trymore Magomana is a regulatory science executive with over 15 years of experience advancing disciplined governance, global health policy alignment, and medical device innovation across U.S., EU, UK, LATAM, and APAC markets. His work integrates complex regulatory frameworks with the practical realities of organizational leadership—ensuring that innovation, safety, and compliance advance together with clarity and integrity.
He specializes in transforming fragmented regulatory environments into coherent, audit-ready systems that support business continuity, market expansion, and responsible decision-making. His leadership reflects a commitment to evidence-based strategy, structured execution, and a global view of health outcomes.
Focus & Advocacy
Systems Leadership & Regulatory Governance
Rather than treating regulation as a constraint, Dr. Magomana advocates for a systems-thinking approach where compliance acts as the operating infrastructure for sustainable innovation. He emphasizes capability-building, the development of empowered teams, and the strategic use of frameworks such as FDA regulations, EU MDR, ISO 13485, MDSAP, and global vigilance systems to drive organizational resilience.
Public Health Integration & Global Policy Insight
Grounded in a Doctor of Public Health (DrPH), his perspective bridges the space between regulatory science and population-level health impact. He focuses on how disciplined execution—across clinical evidence, labeling governance, risk management, and lifecycle oversight—shapes patient safety and health system performance across diverse geographies.
Ethics, Transparency, & Responsible Leadership
His work is guided by a belief that scientific and regulatory progress are inseparable from ethical stewardship. He supports transparent decision-making, balanced risk evaluation, and governance models that maintain public trust in health technologies and the systems that regulate them.
The Path of Insight
Beginning in quality and regulatory engineering roles before progressing into senior leadership positions at Ambu, Abbott, Baxter, Cook Medical, CVRx, and Wipro, Dr. Magomana has built a career defined by clarity in complex environments. He has led multi-market access pathways, EU MDR transitions, FDA submissions, clinical evidence strategies, and portfolio-level risk governance for global life-sciences organizations.
This website serves as a repository for the insights gathered along that journey—capturing lessons learned across regulatory operations, health authority engagement, vigilance, digital regulatory systems, and global compliance architecture. It is a space where professional practice, personal reflection, and scholarly inquiry converge.
Primary Purpose
“To contribute to the global discourse on regulatory science through disciplined inquiry, shared experience, and a steadfast commitment to responsible leadership.”
Executive Leadership & Regulatory Impact
- Global RA/CA leadership across multi-jurisdictional portfolios
- EUDAMED, UDI, vigilance, and lifecycle data governance
- Health authority negotiations and regulatory strategy execution
- MDR transition leadership and regulatory remediation
- Technical file authorship (CERs, CEPs, Design Dossiers)
- FDA and OUS annual reporting, PMA supplement preparation
- Clinical trial regulatory submissions and IDE stewardship
- PMA maintenance for Class III implantable devices
- Global QMS & regulatory alignment (ISO, MDR, MDSAP)
- 510(k), PMA, CE/MDR submissions and lifecycle strategy
- Global regulatory intelligence and cross-functional leadership
- Labeling, UDI, and risk-based compliance systems
- Audit readiness, CAPA governance, and PMS leadership
- UDI, GUDID, and EUDAMED data architecture
- Regulatory submissions and cross-functional program management
- Regulatory strategy consulting for multinational portfolios
- New product development & market entry (U.S., EU, APAC)
- QMS modernization and compliance remediation
- Device safety testing & IEC/ISO compliance evaluations
- ISO 14971 risk analysis and regulatory documentation
- Conformity assessment & certification support
Education & Executive Credentials
A multidisciplinary foundation spanning regulatory science, public health, ethics, and international strategy—supporting high-stakes decision-making across global medical device and health-policy environments.
Executive Expertise
Global Regulatory Affairs & Medical Device Executive with 15+ years driving portfolio strategy, enterprise compliance, and cross-functional regulatory governance across Class I–III devices. Experienced in U.S. and OUS registrations, lifecycle leadership, UDI/labeling infrastructure, and regulatory operations modernization. Proven record delivering audit-ready systems, stabilizing complex portfolios, and influencing executive decision-making with disciplined regulatory intelligence.
Building empowered, high-performing RA teams through coaching, capability-building, and cross-functional influence. Oversight of resource planning and succession pipelines.
Driving executive decisions for 510(k), PMA, De Novo, EU MDR, and APAC pathways. Leading risk-to-market analyses for new technologies.
Direct interface with FDA, Notified Bodies, and regulators. Managing Q-submissions, deficiency responses, and negotiations to maintain continuity.
Leadership of submissions, change control, and maintenance. Ensuring data integrity across DRLM/FURLS, GUDID, and EUDAMED infrastructures.
Expertise in UDI, labeling governance, ad-promo review, and post-market surveillance. Driving vigilance reporting, MDR, and complaint-handling alignment.
Oversight of ISO 13485, 21 CFR 820, MDSAP, ISO 14971, and FMEA frameworks. Supporting audits, CAPA governance, and lifecycle risk controls.
Implementation of RIM systems, structured data, and enterprise reporting. Ensuring data harmonization across global systems (SAP, Trackwise).
Navigating escalations, supply-chain disruptions, and field actions. Partnering with legal and operations to restore compliance and business continuity.
- RAC-Devices® (Regulatory Affairs Certification)
- Doctor of Public Health (DrPH)
- Master of Regulatory Affairs (MRA)
- Master of Business Admin (MBA)