Regulatory Affairs & Quality Specialist

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.

• Regulatory affairs and quality management knowledge: Understanding of regulatory documentation, quality management systems, and compliance processes relevant to regulated products.

• Knowledge of ANVISA requirements: Familiarity with Brazilian regulatory expectations, particularly Good Distribution Practices, Good Storage Practices, and associated documentation requirements.

• Documentation and record management: Strong organizational skills and the ability to prepare, maintain, review, and track regulatory files, procedures, and quality records accurately.

• Quality process experience: Familiarity with non-conformity management, CAPA monitoring, audit support, and the qualification or requalification of distributors and service providers.

• Regulatory and technical vigilance support: Ability to assist with registration dossiers, risk revalidations, field action documentation, and technical vigilance activities.

• Digital tools and tracking systems: Ability to maintain structured records and update tracking platforms such as Smartsheet.

• Attention to detail and analytical thinking: A methodical approach to documentation, process monitoring, issue follow-up, and compliance-related tasks.

• Communication and teamwork: Ability to collaborate with Responsible Technicians, Co-Responsible Technicians, managers, and cross-functional teams across regional operations.

• Proactivity and accountability: Willingness to follow established procedures, identify uncertainties, seek guidance when necessary, and manage assigned activities reliably.

• Adaptability and professional integrity: Commitment to corporate policies, quality standards, confidentiality, and consistent regulatory compliance.