Regulatory Affairs & Quality Specialist

Job Title

Regulatory Affairs & Quality Specialist

Location(s)

Brazil - Remote (Home Based), São Paulo

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity

Main

Duties and Responsibilities

• Prepare drafts of the registration dossier and risk revalidations (Risk I, II, III, and IV) for Revvity Brazil, as requested by the immediate manager, for review and approval.
• Keep the Brazil RMP updated and well organized.
• Maintain Smart Sheet(s) up to date according to the manager’s guidance.
• Support the management of Good Distribution and Storage Practices (GDP/GSP) for ANVISA, together with the other Responsible Technicians (RTs) or CoRTs, at the 3PL site.
• Open and follow up on Non-Conformities.
• Monitor CAPAs together with the relevant departments/areas.
• Control QMS LATAM documents.
• Support distributor qualification and requalification audits.
• Support the qualification and requalification of service providers.
• Responsible for delivering documents related to field actions and technical vigilance (tecnovigilância) in LATAM, jointly with the other RTs and CoRTs of the company.
• Keep regulatory files organized according to the manager’s guidance.
• Draft and maintain procedures for the regulatory affairs area and GDP/GSP (ANVISA) within the LATAM QMS.
• Work routinely, always following the processes already described; in case of doubts, proactively seek guidance from the manager.
• Other occasional activities, as agreed with the manager.
• Comply with all Revvity Inc. policies and the QMS LATAM procedures that are inherent to their tasks.