Profesional de Asuntos Regulatorios - Dispositivos Médicos
Core
Ensure regulatory compliance and submit product registrations for medical devices in Mexico.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and compliance documentation for medical devices
Domain
Healthcare / Medical Devices
Required skills
Regulatory requirements analysis, Product registration submission, Post-market surveillance management, Quality management systems, ISO13485 knowledge, Advanced English
Preferred skills
Portuguese, SAP, Salesforce
Responsibilities
Ensure compliance with regulatory procedures and internal processes, Identify and implement Mexican regulatory requirements for medical devices, Plan and execute product registration submissions to COFEPRIS, Prepare documentation for audits and inspections, Manage post-market surveillance programs, Monitor KPIs
Seniority
Mid-level, hands-on IC