Analista de Asuntos Regulatorios
Core
Regulatory Affairs Analyst preparing, managing, and tracking regulatory filings to launch medical products across Latin American markets.
Role type
Regulatory Affairs Analyst
Builds
Medical product registrations and regulatory dossiers for Latin America
Domain
Healthcare / Medical Devices
Required skills
Regulatory filing preparation, dossier management, multi-country compliance, ERP system management, financial coordination, technical documentation administration
Preferred skills
Specialization in Regulatory Affairs, administrative training
Technologies
ERP systems
Responsibilities
Submit regulatory filings for product registrations, modifications, and renewals to health authorities; Manage new product registration requests; Coordinate with factories for dossier preparation; Track regulatory processes to approval; Maintain regulatory databases; Administer technical and legal documentation; Support bidding processes with technical documentation; Coordinate payments with Finance.
Seniority
Mid-level, 2+ years experience