Revvity | 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.
Regulatory Compliance:
- Interpret and apply regional regulatory requirements and standards specific Thailand (Thai FDA) and any other regulations.
- Stay updated with evolving regulatory changes and communicate their impact on product development and approval processes.
- Prepare and submit regulatory submissions, including product registrations, variations, and renewals, to Thai FDA.
- Collaborate with internal teams to gather necessary technical documentation and data for regulatory submissions in accordance with Thai Medical Device regulatory requirements.
Regulatory Strategy:
- Develop and implement regulatory strategies to support the successful approval and commercialization of medical devices.
- Provide regulatory guidance to cross-functional teams on regional regulatory requirements and strategies for new product development.
- Conduct regulatory assessments for product changes, labeling updates, and manufacturing process modifications.
- Participate in regulatory meetings with authorities to address queries, provide clarifications, and support regulatory approvals.
Regulatory Compliance Audits and Inspections:
- Assure continuous compliance with Health Surveillance Agency’s regulation
- Support internal and external audits and inspections related to regulatory compliance within APAC markets.
- Support global recalls and field action.
Regulatory Intelligence and Training:
- Monitor changes in regulatory requirements, standards, and guidance documents.
- Conduct training sessions and provide guidance to internal stakeholders.
Collaborate with regional regulatory affairs organizations and industry associations within APAC to stay informed about regional best practices and regulatory trends.