Regulatory Affairs – Quality Specialist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Prepare preliminary drafts of registration dossiers and risk revalidations for Revvity Brazil for managerial evaluation and approval.

• Ensure that the Brazil RMP remains updated and well-organized.

• Maintain Smart Sheet(s) in accordance with managerial instructions.

• Assist in the management of Good Distribution and Storage Practices (GDP/GSP) for ANVISA alongside Responsible Technicians and CoRTs at the 3PL site.

• Initiate and follow up on Non-Conformities.

• Oversee CAPAs in collaboration with relevant departments and areas.

• Manage QMS LATAM documents.

• Support audits for distributor qualification and requalification.

• Aid in the qualification and requalification of service providers.

• Provide documents related to field actions and technical vigilance (tecnovigilância) in LATAM in coordination with company RTs and CoRTs.

• Organize regulatory files following managerial guidance.

• Draft and maintain procedures for regulatory affairs and GDP/GSP (ANVISA) within the LATAM QMS.

• Adhere to established processes and proactively seek managerial advice when necessary.

• Undertake other occasional tasks as agreed with the manager.

• Follow Revvity policies and QMS LATAM procedures pertinent to the role.

⛳️ Requirements

• Experience, education, certifications, language requirements, and other qualifications are not specified in the posting.

🏝️ Benefits

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