Job Description
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...