Regulatory Affairs – Quality Specialist

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Logo of Revvity

Revvity

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Revvity is a science-based solutions company that leverages innovation across life sciences and diagnostics to improve lives everywhere. The company serves a diverse customer base, including academia, pharma/biotech, clinical laboratories, and healthcare professionals. Its extensive range of products and services includes genomic analysis, clinical diagnostics, cell and gene therapy, drug discovery, precision medicine, and advanced automation solutions. Revvity is committed to empowering scientists with cutting-edge tools and comprehensive solutions to enhance research and development, diagnostics, and clinical testing. With a focus on accelerating time to market while ensuring quality, Revvity is dedicated to revolutionizing next-generation breakthroughs in healthcare and life sciences.

📋 Description

• 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

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

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