Regulatory Affairs & Quality Specialist
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.
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.
Benefits:
Remote work: Home-based working arrangement within Brazil.
Employment type: Full-time position.
International collaboration: Opportunity to work with regional teams and contribute to regulatory and quality activities across Latin America.
Professional development: Exposure to regulatory affairs, quality management systems, audit support, and compliance processes in an international environment.
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