Revvity is a healthcare and life sciences company that develops solutions for research, diagnostics, and clinical testing. Its products and services support genomic analysis, drug discovery, precision medicine, cell and gene therapy, clinical diagnostics, and laboratory automation. Revvity works with customers across academia, pharmaceutical and biotechnology companies, clinical laboratories, and healthcare, helping teams advance scientific research and bring diagnostic and therapeutic innovations to market.
Regulatory Affairs Quality Specialist - Brazil Remote
Support Revvity’s Brazil and LATAM healthcare quality operations through regulatory affairs, ANVISA compliance, QMS management, audits, CAPAs, regulatory files, and technical vigilance documentation.
Description
- Draft registration dossiers and risk revalidations for managerial review and approval
- Maintain the Brazil RMP and Smart Sheets in line with manager guidance
- Support ANVISA Good Distribution and Storage Practices management with Responsible Technicians and CoRTs at the 3PL site
- Open and track Non-Conformities
- Monitor CAPAs with relevant departments
- Manage LATAM QMS documentation
- Support distributor qualification and requalification audits
- Support service-provider qualification and requalification
- Provide LATAM field-action and technical-vigilance documentation with company RTs and CoRTs
- Organize regulatory files according to manager guidance
- Draft and maintain regulatory affairs and ANVISA GDP/GSP procedures within the LATAM QMS
- Follow established processes and seek managerial guidance when necessary
- Complete other occasional activities agreed with the manager
- Follow Revvity policies and applicable LATAM QMS procedures
- Complete other occasional activities agreed with the manager
Requirements
- The posting does not specify experience, education, certifications, language requirements, or other qualifications.