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Regulatory Affair & Quality Assurance Specialist (diagnostic business)

Brunel Technical Services Manpower Corp.
Brunel Technical Services Manpower Corp. (Bangkok)
Bangkok
Bangkok, Thailand 🇹🇭
Brunel Technical Services Manpower Corp.
Brunel provides the customised project and workforce solutions you need to lead your industry. With more than 45 years of market experience in Renewables, Conventional Energy, Mining, Life Sciences, Future Mobility, Industrials & Technology and many other sectors, we help you finish major projects safely, compliantly, on-time, within budget and at the highest quality, so you can keep growing — anywhere in the world.

Detail posisi

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.

Kewajiban

• 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.

Kualifikasi

• 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.