Staff Regulatory Affairs Specialist (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 responsibilities

• 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, Ins...