法规事务与质量专员

Job Title
Regulatory Affairs & Quality Specialist

Location(s)

Brazil - Remote (Home Based), São PauloAbout 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 draftsof the registration dossier and risk revalidations (Risk I, II, III, and IV) forRevvity Brazil, as requested by the immediate manager, for review and approval.

• Keep the Brazil RMPupdated 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 otherResponsible Technicians (RTs) or CoRTs, at the3PL site.

• Open and follow up on Non-Conformities.

• Monitor CAPAstogether with the relevant departments/areas.

• Control QMS LATAM documents.

• Support distributor qualification and requalification audits.

• Support the qualification and requalificationof 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 organizedaccording to the manager’s guidance.

• Draft and maintain proceduresfor the regulatory affairs area andGDP/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. policiesand theQMS LATAM proceduresthat are inherent to their tasks.

Originally posted on Himalayas