Regulatory Affairs Specialist

Regulatory Affairs Specialist

Thailand | Global Medical Technology | Hybrid

This is an exciting opportunity to join a globally recognised medical technology organisation with an impressive portfolio of minimally invasive devices and a strong culture of innovation.

The organisation continues to develop and commercialise technologies across endovascular, gastrointestinal, urological and other specialised medical fields, giving Regulatory Affairs professionals the opportunity to work with complex products and international stakeholders.

As Regulatory Affairs Specialist, you will have end-to-end ownership of the Thailand regulatory agenda, from product registration and change submissions through to licence maintenance, regulatory intelligence and authority engagement.

You'll work closely with global manufacturing sites and internal stakeholders, providing regulatory guidance and helping the business navigate an evolving Thai regulatory environment.

Your responsibilities will include:

• Preparing and reviewing new product and change submissions
• Managing Thai FDA licensing activities
• Supporting product lifecycle and licence maintenance
• Engaging directly with regulatory authorities
• Monitoring regulatory changes and developing appropriate strategies
• Advising internal stakeholders on regulatory requirements
• Supporting regulatory training and awareness

You'll ideally have:

• A degree in Science, Engineering or a related field
• 4 years RA experience in medical devices or pharmaceuticals
• Hands-on submission experience
• Experience communicating with regulatory authorities
• Fluent Thai and English
• Strong organisational and stakeholder-management capabilities

The opportunity

A high-autonomy, international Regulatory Affairs position where you can build depth in Thailand regulations while collaborating with colleagues and manufacturing sites globally.

If you're looking for ownership, exposure and meaningful career development, this could be the next step for you.

Apply confidentially today.

CEI: R2090154 | Licence No.: 22S1313