Quality and Regulatory Affairs

About the role

The Quality & Regulatory Affairs Specialist ensures that all medical devices and related products comply with certified standards, local regulatory requirements, and internal quality policies. Responsible for end-to-end medical device registrations, regulatory lifecycle management, advertising permit approvals, and vital post-marketing surveillance activities—including vigilance reporting, complaint investigations, batch release for sales, and ongoing compliance monitoring throughout the product lifecycle—this role bridges quality assurance with regulatory compliance to guarantee product safety, efficacy and lawful market presence.

Key responsibilities

• Develop, implement, maintain and continuously update departmental processes incorporating risk management in compliance with certified standards and legislation
• Conduct regulatory impact assessments by monitoring regulatory updates, evaluating potential impacts, communicating insights to relevant departments, and following up until full implementation
• Oversee regulatory submission packages to support business activities and maintain full compliance with local laws and regulations
• Liaise with the Thai FDA (TFDA) and relevant authorities for regulatory submissions, consultations, and related official matters, ensuring end-to-end follow-up until approval or completion
• Ensure essential reports are timely and successfully submitted to relevant stakeholders in alignment with regulatory authority requirements and service agreements
• Maintain, update, control and distribute all confidential documents whether quality system or regulatory affairs to authorized persons appropriately, in a timely manner and in compliance with company policy, laws and regulations
• Ensure all incoming, returned, and redressed products undergo appropriate physical inspections prior to warehouse receipt or release for sale; execute disposition decisions to quarantine suspected items or release conforming products based on specifications
• Conduct verification and validation activities including temperature mapping and measuring device calibration at defined intervals, verifying that storage conditions and transportation environments meet established product specifications
• Collaborate with the operations team to monitor and address post-marketing surveillance activities including NCRs, CARs/PARs, customer feedback, change requests, and vigilance processes, ensuring all actions are promptly and effectively executed and closed
• Support the Lead IQA in conducting quality audits and regulatory inspections involving relevant stakeholders, ensuring company-wide compliance and successful audit execution

About you

• Bachelor's Degree in Science, Medical Science and Technology or other related fields
• Minimum 0-2 years of experience in Regulatory Affairs Field, especially medical devices
• Strong logical thinking and interpersonal skills
• Good computer literacy, especially in MS Office applications
• Strong documentation and record management skills
• Good command of spoken and written English