Staff Regulatory Affairs Specialist

Role Overview

• Support the Neurovascular Division in Brazil, ensuring regulatory compliance for Class III and IV medical devices.
• Prepare, submit, and maintain regulatory submissions to ANVISA for Class III and IV medical devices.
• Maintain product registrations and support new product launches in Brazil.
• Provide regulatory guidance on product lifecycle changes.
• Ensure full adherence to the Brazilian Quality Management System.
• Review and approve labeling, Instructions for Use, and promotional materials.
• Support regulatory intelligence activities and monitor regulatory updates.
• Maintain accurate regulatory documentation and ensure regulatory systems are properly updated.
• Collaborate with Design Divisions, LATAM regional teams, and cross-functional stakeholders for regulatory support.

Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Regulatory Affairs experience in the medical device industry.
• Strong experience with ANVISA regulations, including solid knowledge and applicability of RDCs.
• Demonstrated experience managing medical device registrations, particularly for Class III and IV products.
• Experience with Regulatory Intelligence activities and interaction with industry associations and health authorities.
• Advanced English (written and spoken).
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint) and Power BI.
• Preferred Master’s degree in Regulatory Science or related field.
• Experience supporting regulatory activities in additional Latin American countries.
• Experience in the medical product registration process for low-risk classification (I and II).
• Knowledge of Brazilian electromechanical certification processes (e.g., INMETRO).
• Spanish proficiency.

Benefits

• N/A