REGULATORY AFFAIRS Analyst Consultant
Core
Ensures proper submission and approvals for market licenses including new registrations, changes, renewals, and establishment registrations for Brazilian Health Authorities.
Role type
Regulatory Affairs Associate Consultant (Contract)
Builds
Market licenses and registration dossiers for medical devices or pharma products
Domain
Life Sciences (Medical Devices/Pharma) in Brazil
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy execution, submission preparation, establishment license management, post-approval activities (labels, IFU), stakeholder interaction, audit support, project management, quality issue management, compulsory certification (INMETRO) management, GMP activities
Preferred skills
Medical Devices or Pharma background, Excel for complex data management
Technologies
Excel
Responsibilities
Elaborate regulatory strategy and execute submissions for changes, new registrations, and renewals; Execute activities to obtain or update establishment registration licenses; Prepare communications, labels, and Instructions for Use; Request and follow up on documentation for registration dossiers; Support regional team on submission schedules and pipeline management; Support internal and external audits; Act as a point of contact for stakeholders; Review label compliance in internal systems; Manage quality issues and compulsory certification (INMETRO) and GMP activities
Seniority
Junior to Mid-level, hands-on IC
