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⏰ Full-time

Staff Regulatory Affairs Specialist (Hybrid)

Stryker
Location 📍 São Paulo, Brazil
Posted 📅 June 14, 2026
Work Type ⏰ Full-time

Position Overview

**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...

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Job Details

Employment Type
Full-time
📊
Category
other-general
🏠
Work Arrangement
On-site
📍
Location
São Paulo, Brazil