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 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

• Bachelors 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

• Masters 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.