Senior International Regulatory Affairs Specialist
Core
Leads international regulatory submissions and registrations for medical devices across multiple global regions.
Role type
Senior International Regulatory Affairs Specialist
Builds
Regulatory submissions, registrations, and lifecycle management for medical device products
Domain
Medical Technology / Regulatory Affairs
Required skills
International regulatory strategy, Design History File (DHF) navigation, Technical File (STED) management, risk assessment, change control, regulatory impact assessment, cross-functional collaboration, compliance tracking
Preferred skills
Experience with CASAJ, Greater China, LATAM, Canada, EMEA markets, SAP/MasterControl/JDE systems, Microsoft Office AI tools
Technologies
SAP, MasterControl, JDE, Microsoft Office (Word, Excel, PowerPoint, PowerBi), AI Copilot
Responsibilities
Lead collection and analysis of country-specific regulatory requirements; Drive international registrations per project plan; Review and approve technical documentation for submissions; Develop and execute regulatory strategies for product lifecycle; Identify regulatory risks and develop mitigation plans; Coordinate responses to regulatory authority questions and deficiency letters; Compile regulatory impact assessments and status updates for Supply Chain; Obtain Regulatory Certificates (CFGs, FSCs); Support global product lifecycle activities including renewals and labeling updates
Seniority
Senior, hands-on IC