[Thailand] Regulatory Affairs Consultant – Contact Lens Registration

We are seeking a experienced regulatory affairs specialist to manage and support the product registration process for contact lenses with the Thai FDA. The primary responsibility is to ensure full compliance with local regulatory requirements and streamline the approval process. We already hold a valid Thai establishment license.

Key Responsibilities:
- Lead and manage the entire product registration process for contact lenses with the Thai FDA.
- Prepare, meticulously review, and submit all necessary regulatory documentation.
- Serve as the main point of contact and liaison with Thai FDA authorities throughout the registration lifecycle.
- Maintain direct communication with the Thai FDA, providing prompt responses to inquiries, clarifications, and requests for additional documents.
- Actively support and address any FDA questions during the review process to ensure timely progress and avoid delays.
- Provide expert advice on regulatory requirements, expected timelines, and potential risks associated with the registration.
- Ensure strict compliance with all applicable medical device and optical product regulations in Thailand.
- Implement strategies to streamline the registration workflow, aiming for a smooth and efficient approval process.

Requirements:
- Proven, hands-on experience in Thai FDA medical device registration, with a strong preference for ophthalmic products or contact lenses.
- In-depth understanding of Thai medical device regulations and the classification system.
- Demonstrated prior experience in direct communication with Thai FDA officers and effectively handling regulatory inquiries.
- Ability to independently manage and support the registration process from initial submission through to final approval.
- Fluency in Thai is essential, complemented by professional English communication skills.
- Strong responsiveness and the capability to manage time-sensitive regulatory questions efficiently.
- An existing network or familiarity with FDA procedures in Thailand is highly preferred.

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.