Regulatory Affair & QA Specialist

We have a current opportunity for a Regulatory Affair & QA Specialist.

The position will be based in Bangkok Thailand.

Major responsibility

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.