Regulatory Affairs Specialist
Location(s): 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 diverse 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.
Responsibilities
1. Prepare draft dossiers for product registrations with regulatory authorities for Revvity Brasil.
2. Maintain and organize the Master Repository of records for Brazil and Mexico.
3. Keep the Smart Sheet(s) up to date as directed by the manager.
4. 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.
5. 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:
1. Conduct audits of incoming and outgoing goods.
2. Implement SOPs with the 3PL.
3. Support the Quality Manager in audits with the 3PL.
4. Open incidents and monitor 3PL responses.
5. Track 3PL SLAs.
6. Keep regulatory files organized as directed by the manager.
7. Follow all Revvity Inc. policies and LATAM QMS procedures related to your tasks.
8. Act proactively by bringing solutions to problems and continuously improving activities.
9. Work routinely but always follow the described processes, and in case of doubts, proactively seek guidance from the manager.
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