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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs and Good Distribution Practices (GDP) within the LATAM region, ensuring compliance with ANVISA regulations and maintaining organized regulatory files. Proficient in managing Quality Management System (QMS) documents and supporting distributor qualification audits.
Highest-signal resume keywords
Regulatory Affairs ManagementGood Distribution Practices (GDP)Quality Management System (QMS)Non-Conformity ManagementDistributor Qualification Audits
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Tools & Technologies
Smart Sheet
Industry Keywords
ANVISARisk RevalidationField ActionsTechnical VigilanceCoRTsResponsible TechniciansCAPA MonitoringQMS LATAMRegulatory DossiersService Provider Qualification
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Experience, education, certifications, language requirements, and other qualifications are not specified in the posting.
