EPR Compliance Specialist ensuring timely EPR filings and reporting for clients in Germany. Managing client accounts and handling reports while collaborating with the Finance team.
About the role
- Regulatory Affairs Specialist ensuring compliance for Class III and IV medical devices in Brazil. Collaborating within a LATAM matrix structure to provide regulatory guidance and support.
Responsibilities
- Support the Neurovascular Division in Brazil, ensuring regulatory compliance for Class III and IV medical devices.
- Prepare, submit, and maintain regulatory submissions to ANVISA for Class III and IV medical devices.
- Maintain product registrations and support new product launches in Brazil.
- Provide regulatory guidance on product lifecycle changes.
- Ensure full adherence to the Brazilian Quality Management System.
- Review and approve labeling, Instructions for Use, and promotional materials.
- Support regulatory intelligence activities and monitor regulatory updates.
- Maintain accurate regulatory documentation and ensure regulatory systems are properly updated.
- Collaborate with Design Divisions, LATAM regional teams, and cross-functional stakeholders for regulatory support.
Requirements
- Bachelor’s 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 Power BI.
- Preferred Master’s 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.
Benefits
- N/A
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Compliance Analyst helping financial institutions assess risks and verify customers through compliance operations at fintech VFX Financial.
Data Protection & Compliance Officer at Qualco Group focusing on regulatory compliance and data protection. Collaborating with operational teams and reporting to the Compliance Manager for effective implementation.
Regulatory Affairs Specialist managing regulatory processes for TidalSense medical devices in various global markets. Preparing submissions and ensuring compliance in fast - paced healthcare environment.
Associate Compliance Officer driving differentiated client experiences through margin and covenant processes at RBC. Collaborating with stakeholders and ensuring compliance in commercial financial services operations.
Consultant GRC managing cybersecurity projects including risk assessment and compliance audits. Collaborating with clients for robust cybersecurity governance at Thales Cyber Solutions.
Senior Global Regulatory Scientist at ICON supporting regulatory strategies for clinical development programmes. Collaborating with cross - functional teams to ensure compliant study designs and submissions.
Regional Regulatory Data Compliance Manager optimizing regulatory data processes for GSK. Collaborating with teams to enhance compliance and inspection readiness of regulatory activities.
Lead regulatory strategy for precision medicine and digital health at GSK. Collaborate with teams to ensure compliant development across multiple regions including USA and UK.
Compliance Officer responsible for day - to - day compliance activities for Aviso's Correspondent Partners business line. Monitoring trading activities and managing compliance projects.