[Thailand] Regulatory Affairs Consultant – Contact Lens Registration (Thailand Fda)

We are seeking an experienced Regulatory Affairs professional in Thailand to support the registration of contact lenses with the Thai Food and Drug Administration (Thai FDA).

About the Role
We already hold a valid Thai establishment license. The primary responsibility of this role is to manage and support the product registration process for contact lenses with the Thai FDA, ensuring full compliance with local regulatory requirements and helping to streamline the process for a smooth and efficient approval.

Key Responsibilities
Lead and manage the product registration process for contact lenses with the Thai FDA
Prepare, review, and submit all required regulatory documentation
Act as the primary liaison with Thai FDA authorities throughout the registration process
Communicate directly with the Thai FDA and remain available to respond promptly to any inquiries, clarifications, or additional document requests
Support and address FDA questions during the review process to ensure timely progress
Advise on regulatory requirements, timelines, and potential risks
Ensure compliance with all applicable medical device and optical product regulations in Thailand
Help streamline the registration workflow to ensure a smooth and efficient approval process

Requirements
Proven experience in Thai FDA medical device registration (preferably ophthalmic products or contact lenses)
Strong understanding of Thai medical device regulations and classification system
Prior experience communicating directly with Thai FDA officers and handling regulatory inquiries
Ability to independently manage and support the registration process from submission to approval
Fluent in Thai (required) and professional English communication skills
Strong responsiveness and ability to manage time-sensitive regulatory questions
Existing network or familiarity with FDA procedures is highly preferred

Engagement Type
Product-based (project-based until registration completion)

Location
Must be in Thailand. If in Bangkok it would be best where we have our office location.

If you have relevant experience or are a regulatory consultant familiar with contact lens or medical device approvals in Thailand, please contact us with your background and relevant past projects.