Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist

Thailand | International Stakeholder Exposure | Medical Devices

Local regulatory expertise. Global reach.

We are seeking a Regulatory Affairs Specialist to join a global medical technology organisation with an extensive portfolio of minimally invasive products.

What makes this opportunity particularly attractive is the international nature of the role.

While your primary responsibility will be the Thailand regulatory environment, you'll work closely with manufacturing facilities and stakeholders across a global organisation.

You'll become the local regulatory expert who helps international teams understand Thailand's requirements and ensures products and changes can successfully navigate the local regulatory pathway.

Your responsibilities will include:

• Product registrations and licence maintenance
• Preparation of new product and change submission dossiers
• Thai FDA submissions and additional licences
• Regulatory authority negotiation and communication
• Regulatory intelligence and impact assessment
• Development of regulatory strategies and solutions
• Training and regulatory awareness for internal stakeholders
• Cross-functional collaboration with global teams

About you:

You have 6 years Regulatory Affairs experience within medical devices or pharmaceuticals and are comfortable owning regulatory submissions from preparation through to authority interaction.

You'll be fluent in Thai and English and bring excellent organisational, communication and stakeholder-management skills.

The role:

This is a sole-contributor professional role with meaningful autonomy, international exposure and the opportunity to become a key regulatory point of contact for Thailand.

Hybrid working, 3 days in office.

If you're looking for a role that combines technical regulatory expertise with international collaboration, let's connect.

CEI: R2090154 | Licence No.: 22S1313