Regulatory Affairs & Quality Specialist

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Regulatory Affairs & Quality Specialist based in Brazil. We are seeking a detail-oriented Regulatory Affairs & Quality Specialist to support regulatory compliance, quality management, and product safety activities across Brazil and Latin America. In this role, you will help prepare regulatory documentation, maintain organized compliance records, and support processes aligned with applicable ANVISA requirements and regional quality management standards. You will collaborate with Responsible Technicians and cross-functional teams to manage non-conformities, corrective and preventive actions, audits, and technical vigilance documentation. Your work will contribute to the reliability of distribution and storage practices, the qualification of external partners, and the consistent application of quality procedures. This is an opportunity to strengthen regulatory processes in a collaborative, international environment while supporting the delivery of solutions that contribute to better human health. The position is full-time and remote within Brazil. Accountabilities - Prepare regulatory documentation: Draft registration dossiers and risk revalidation documentation for Risk Classes I, II, III, and IV, as requested by the manager, ensuring materials are ready for review and approval. - Maintain regulatory management records: Keep the Brazil Regulatory Management Plan (RMP) current, accurate, and well organized, and maintain regulatory files according to established guidance. - Manage tracking systems: Update and maintain Smartsheet records in accordance with management instructions and applicable workflows.

- Support distribution and storage compliance: Assist with the management of Good Distribution Practices (GDP) and Good Storage Practices (GSP) in line with ANVISA requirements, working alongside Responsible Technicians and Co-Responsible Technicians at third-party logistics (3PL) facilities. - Manage non-conformities: Open, document, and follow up on non-conformities, ensuring appropriate tracking and communication throughout the resolution process. - Monitor corrective and preventive actions: Coordinate with relevant departments to track Corrective and Preventive Actions (CAPAs), supporting timely follow-up and adherence to quality requirements. - Maintain quality management documentation: Control and organize Latin American Quality Management System (QMS) documents, ensuring records remain accurate, accessible, and aligned with established procedures. - Support audits and partner qualification: Assist with distributor qualification and requalification audits, as well as the qualification and periodic reassessment of service providers. - Coordinate technical vigilance documentation: Help prepare and deliver documentation related to field actions and technical vigilance (tecnovigilance) across Latin America, in collaboration with the relevant Responsible Technicians and Co-Responsible Technicians. - Develop and maintain procedures: Draft, review, and maintain Regulatory Affairs and GDP/GSP procedures within the regional QMS, supporting consistent practices and ongoing compliance. - Follow established processes: Perform daily activities in accordance with approved procedures, proactively seeking managerial guidance whenever clarification is needed. - Ensure policy compliance: Adhere to applicable corporate policies and regional QMS procedures relevant to assigned responsibilities. - Support additional activities: Undertake other related tasks as agreed with the manager to support the team's regulatory and quality objectives. Requirements: - Regulatory affairs and quality management knowledge: Understanding of regulatory documentation, quality management systems, and compliance processes relevant to regulated products.