Regulatory Affair & Quality Assurance Specialist (diagnostic business)
About this position
The Regulatory Affair & Quality Assurance Specialist is responsible for ensuring regulatory compliance and developing strategies for the approval and commercialization of medical devices in the diagnostic business.
Responsibilities
• 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.
• 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.
• 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.
• 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.
Requirements
• Bachelor’s degree in related field (such as science, chemistry, medical or engineering discipline).
• Fluent English.
• 3 - 5 years experience in medical device RA/QA, IVD work experience is preferred.
• Experience in preparing and submitting regulatory filings and registrations for IVD medical devices in SEA region is preferred.
• Familiarity with regional regulatory requirements, including registration processes, technical documentation, and labeling guidelines.
• Strong attention to detail and ability to work independently and collaboratively.
• Good communication skill and negotiation skill with stakeholders.
• 10% - to visit Customer / dealer / distributor, medical centre, clinics or hospital with biohazard and chemical exposure occasionally.