Strategic and globally experienced Regulatory Affairs leader with 17+ years of success driving regulatory strategy, policy alignment, and compliance across 200+ international markets. Proven expertise in navigating complex regulatory landscapes for Class II and III medical devices. Adept at translating global regulatory intelligence into actionable strategies that accelerate market access, minimize risk, and inform product lifecycle planning.
Global Regulatory Strategy & Compliance
- Direct interaction with FDA, Notified Bodies, and Competent Authorities
- Regulatory submissions (510(k), eSTAR), CE Marking, UKCA, FURLS, Canadian licenses
- Technical Documentation, Design History Files, Risk Management Files
- Regulatory SOP development and optimization
Audit, Surveillance & Quality Systems Integration
- ISO 13485, ISO 14971, ISO 9001, MDSAP, and QMS oversight
- Field actions, recalls, CAPA, Health Hazard Evaluations
- Internal auditing and surveillance audit preparation (UKCA, MDR)
- QMS Regulatory Process Ownership
Regulatory Intelligence & Policy Application
- Interpretation of global regulatory trends and guidance (FDA, MDR, IMDRF)
- Support dissemination of regulatory intelligence
- Maintenance of state-of-the-art standards and compliance strategies
- Contributor to multiple International technical standard committees
Leadership & Regulatory Operations
- Regulatory stakeholder coordination across business units
- Regulatory metrics, KPIs, and document control system implementation
- Team leadership: Directly managed multiple level regulatory departments
- Served as Deputy PRRC for 150+ EU Technical Files
