Regulatory Affairs – Quality Specialist

• Prepare drafts of registration dossiers and risk revalidations for Revvity Brazil for managerial review and approval
• Keep the Brazil RMP updated and organized
• Maintain Smart Sheet(s) according to manager guidance
• Support Good Distribution and Storage Practices (GDP/GSP) management for ANVISA with Responsible Technicians and CoRTs at the 3PL site
• Open and follow up on Non-Conformities
• Monitor CAPAs with relevant departments and areas
• Control QMS LATAM documents
• Support distributor qualification and requalification audits
• Support qualification and requalification of service providers
• Deliver documents related to field actions and technical vigilance (tecnovigilância) in LATAM with company RTs and CoRTs
• Keep regulatory files organized according to manager guidance
• Draft and maintain regulatory affairs and GDP/GSP (ANVISA) procedures within the LATAM QMS
• Follow established processes and proactively seek managerial guidance when needed
• Perform other occasional activities agreed with the manager
• Comply with Revvity policies and QMS LATAM procedures inherent to the role

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