Compliance Analyst ensuring adherence to legal and company standards at Copa Energia, monitoring training programs and supporting data protection compliance.
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
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