Regulatory Affairs Analyst

Responsibilities

• Supports the execution of regulatory planning and operational activities across LATAM for Electrophysiology (EP) and Neurovascular (NV) portfolios
• Supports dossier delivery to Local Operating Companies (LoCs)
• Contributes to data-driven decision-making and drives process standardization to enable efficient lifecycle management (LCM) and new product introductions (NPI)
• Executes the preparation and delivery of regulatory dossiers to LoCs ensuring completeness and compliance with local requirements
• Tracks dossier submission timelines and ensures alignment with regulatory action plans and market needs
• Supports document management activities, including version control
• Acts as a liaison between regional teams and LoCs to ensure clarity on dossier requirements
• Contributes to planning and forecasting activities
• Maintains regional trackers, dashboards, and planning tools
• Consolidates and analyzes regulatory performance metrics
• Identifies opportunities to improve planning, dossier delivery, and operational processes

Requirements

• Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or related field
• 0–2 years of experience in Regulatory Affairs or related field
• Strong analytical and problem‑solving skills
• High attention to detail and process orientation
• Proficiency in Excel; data visualization tools (e.g., Power BI) is a plus
• Advanced or intermediate skills in English/ Spanish is preferred.

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