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 (tecnovigilncia)   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.