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.