Quality and Regulatory Affairs Associate - J.S. Vision Ltd.

1. Oversee regulatory submission packages to support business activities and maintain full compliance with local laws and regulations.
2. 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.
3. Ensure that the essential reports are timely and successfully submitted to relevant stakeholders in a timely manner, aligning with regulatory authority requirements and service agreements with product owners/suppliers/clients.
4. 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.
5. Act as the Document Control Center to establish, maintain, and update documentation procedures, while ensuring records are controlled, accessible, readily retrievable, and retained for the defined period.
6. Ensure verification and validation activities (i.e., temperature mapping and measuring device calibration) are conducted at defined intervals to verify that storage conditions and transportation environments meet established product specifications.
7. Support the Lead IQA in conducting quality audits and regulatory inspections involving relevant stakeholders, ensuring company-wide compliance and a successful audit execution.
8. Perform other tasks as assigned by the Manager.

• Bachelor's degree in Science, Medical Science and Technology, or a related field
• 0-2 years of experience in Regulatory Affairs, particularly with medical devices
• Strong logical thinking and interpersonal skills
• Proficiency in Microsoft Office applications
• Strong documentation and record management skills
• Proficiency in spoken and written English

Founded in 1995, we sailed through the most difficult years (1997-2001) of financial crisis. We transformed ourselves from a US& 1.5 million firm to US$ 14 million business in 2008. The company is owned by ex-multinational company employees with depth knowledge of international medical device distribution as well as logistics for health-care products. We have our head office and distribution centers (DC) in Bangkok.