Dr. Trymore Magomana

DrPH • MBA • RAC-Devices®
Regulatory Affairs Leader | Medical Devices | Global Markets

Resume landing page for recruiters and hiring leaders. This page summarizes role fit, executive scope, and core competencies—then links directly to the PDF resume.

Target roles: Sr. Manager / Director (RA • RA/CA • Compliance • Vigilance) U.S. • Canada • EU/UK • LATAM • APAC
Recruiter Snapshot
Regulatory leader with enterprise experience across medical device submissions, EU MDR, vigilance, and global compliance governance.
Strength areas: inspection readiness, lifecycle governance, authority engagement, and decision frameworks that scale.
Industries
Medical Devices
Credential
RAC-Devices®
Core
EU MDR • FDA
Domains
Vigilance • QMS • Risk
Executive highlights
  • Led multi-region regulatory and clinical/vigilance execution across U.S., Canada, EU/UK, LATAM, and APAC.
  • Owned EU MDR lifecycle governance artifacts (CER/PMS/SSCP) and post-market alignment.
  • Strengthened inspection readiness via CAPA/Change Control and evidence-ready decision cadence.
  • Delivered multiple FDA 510(k) submissions end-to-end, aligning claims, indications, testing strategy, labeling, and risk documentation to reduce review friction and protect timelines.
  • Led EU MDR technical documentation execution with Notified Bodies (SGS, BSI), coordinating CER/PMS/PMCF artifacts, technical file completeness, and audit-ready evidence packages.
  • Owned EUDAMED readiness and execution, including UDI data governance, stakeholder alignment, and operational workflows to sustain compliance at scale.
  • Stabilized FDA Establishment Registration & Device Listing (FURLS/DRLM) across multiple organizations, preventing “data drift,” duplicate listings, and continuity risks that can trigger shipment holds.
  • Authored and governed Clinical Evaluation Reports (CERs) and associated MDR lifecycle documents (PMS Plans/Reports, SSCP inputs where applicable), ensuring defensible clinical/benefit-risk narratives aligned to intended use and post-market signals.
  • Built inspection-readiness as a management system, translating CAPA, complaint/vigilance trends, and change control into proactive governance routines (not “panic prep”).
  • Led Health Authority engagement and response management, producing authority-grade communications, structured commitments, and evidence-backed rationales that reduce back-and-forth cycles.
  • Operationalized risk management (ISO 14971) across lifecycle decisions, ensuring hazards, mitigations, labeling controls, and post-market feedback loops remained aligned and auditable.
  • Enabled global market access execution across U.S., Canada, EU/UK, LATAM, and APAC, aligning portfolio strategy to regional requirements while maintaining a single source of truth for regulatory records.
  • Improved cross-functional execution velocity by clarifying roles (RACI), decision checkpoints, and escalation pathways—reducing ambiguity between RA/QA, Clinical, Engineering, Supply Chain, and Marketing.
Core domains (at-a-glance)
FDA • 510(k) • EU MDR • Notified Bodies (SGS, BSI) • CER/PMS/PMCF • Vigilance • UDI • EUDAMED • Risk (ISO 14971) • CAPA • Change Control • Technical Documentation • Market Access • Authority Engagement
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Valid through 2026.