Regulatory Affairs Specialist

Há 4 dias

São Paulo, Brasil Revvity Tempo inteiro

Prepare draft dossiers for product registrations with regulatory authorities for Revvity Brasil.- Maintain and organize the Master Repository of records for Brazil and Mexico.- Keep the Smart Sheet(s) up to date as directed by the manager.- Communicate with the GTS team regarding new registrations and revalidations in LATAM, ensuring that the GTS is updated and accurate according to the information provided.- Assist in ANVISA Good Distribution and Storage Practices at the company’s branch site in Barueri, where presence is required 1 to 2 times per week to:- Conduct audits of incoming and outgoing goods- Implement SOPs with the 3PL- Support the Quality Manager in audits with the 3PL- Open incidents and monitor 3PL responses- Track 3PL SLAs- Keep regulatory files organized as directed by the manager.- Follow all Revvity Inc. policies and LATAM QMS procedures related to your tasks.- Act proactively by bringing solutions to problems and continuously improving activities.- Work routinely but always follow the described processes, and in case of doubts, proactively seek guidance from the manager

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