Staff Regulatory Affairs Specialist (Hybrid)

Work Flexibility: Hybrid

What you will do

In this role, you will support the Neurovascular Division in Brazil, ensuring regulatory compliance for Class III and IV medical devices while collaborating within a LATAM matrix structure.

Main responsabilities:

• Prepare, submit, and maintain regulatory submissions to ANVISA for Class III and IV medical devices, including monitoring authority reviews and managing follow-up actions.

• Maintain product registrations and support new product launches in Brazil, ensuring compliance with applicable RDCs and local regulatory requirements.

• Provide regulatory guidance on product lifecycle changes, including Change Notification assessments, impact analysis, filing strategy, and development of local regulatory action plans.

• Ensure full adherence to the Brazilian Quality Management System and applicable regulatory procedures, in coordination with the local regulatory team.

• Review and approve labeling, Instructions for Use, and promotional materials to ensure alignment with regulatory approvals and standards.

• Support regulatory intelligence activities, including monitoring regulatory updates and interacting with industry associations and health authorities as appropriate.

• Maintain accurate regulatory documentation and ensure regulatory systems and tracking tools (e.g., RACM, QuickBase, dashboards) are properly updated.

• Collaborate with Design Divisions, LATAM regional teams, and cross-functional stakeholders to ensure timely regulatory support, including documentation for tenders, importation activities, and ERP processes.

What you need

Required

• 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 PowerBI.

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.

Travel Percentage: 10%