Compliance: Act in accordance with laws and regulations (such as FCPA) and Stryker’s Code of Conduct, upholding the highest ethical standards.
Regulatory Affairs: Responsible for product registrations, item maintenance, certifications (INMETRO, ANATEL), and supporting import clearance processes.
Product Registrations: Prioritize, plan, and manage regulatory submissions for changes, and renewals across all risk classes (I–IV), including GMP, INMETRO, and ANATEL certifications.
Interaction with Health Authorities: Prepare and submit dossiers, respond to ANVISA inquiries, and actively monitor approval status.
Cross-Functional Communication: Provide regulatory status updates to local Marketing teams and international RA teams, ensuring alignment across processes.
Audit & Tender Support: Participate in internal and corporate audits, providing regulatory documentation and supporting corrective actions when needed.
Analytics & KPIs: Deliver accurate data for monthly KPIs and management reports, identifying continuous improvement opportunities.
Documentation & Procedures: Maintain organized RA intelligence files, identify the need for new SOPs, and support process development in Regulatory Affairs.
Bachelor’s degree in a healthcare-related field
Experience with Microsoft Office Suite
Knowledge and experience with Ordinance 384/2020, RDC 751/2022, and preferably Quality Standard 665/2022
Previous experience in the medical devices industry (required)
Intermediate to advanced English proficiency
Spanish is a plus
Travel Percentage: 10%