Staff Regulatory Affairs Specialist
Core
Develop and maintain regulatory reporting, create Power BI dashboards, and analyze large datasets to translate regulatory data into actionable business insights for registration prioritization and market access.
Role type
Senior Regulatory Analytics & Business Intelligence Specialist
Builds
Executive-level regulatory dashboards, metrics, and reporting systems
Domain
Medical Technology / Regulatory Affairs / Business Intelligence
Deliverable
dashboards & analysis
Required skills
Power BI, Excel, data analysis, data visualization, AI-enabled reporting, cross-functional collaboration, risk assessment
Preferred skills
Regulatory Affairs experience, knowledge of international medical device regulatory processes, globalization support
Technologies
Power BI, Microsoft Copilot, Microsoft 365, Excel
Responsibilities
Develop weekly/monthly globalization and regulatory reporting; Create and manage Power BI dashboards; Analyze regulatory, business, and financial datasets; Translate data into actionable insights for registration and market access; Support registration-to-revenue mapping; Participate in governance forums; Facilitate alignment across Regulatory, Marketing, Finance, and Platform teams; Leverage AI tools for automation; Ensure data accuracy and integrity.
Seniority
Senior, hands-on IC