Head of Regulatory Affairs

Head of Regulatory Affairs – Bangkok, Thailand Keywords: Regulatory Affairs Manager, Compliance, FDA Regulations, EU Regulations, ISO Standards, Product Development, Risk Assessment, Quality Systems, Product Registration, Medical Devices, Hazardous Substance.

An Exciting Opportunity Awaits!
Our client is seeking a highly skilled and experienced Head of Regulatory Affairs to join their team in Bangkok, Thailand. This pivotal role will oversee regulatory compliance for the medical devices and hazardous substance business while collaborating closely with overseas counterparts to drive growth and ensure speed-to-market strategies. If you have a passion for regulatory excellence and a commercial mindset, this is your chance to make an impact in a dynamic and fast-paced environment.

What You'll Do:

As the Head of Regulatory Affairs, you will play a key role in ensuring compliance with global regulatory standards while driving business success. Your responsibilities will include:

• Developing and executing regulatory strategies to ensure compliance with applicable laws and standards.
• Collaborating with cross-functional teams (R&D, Quality Assurance, Legal) to integrate regulatory requirements throughout the product lifecycle.
• Preparing and submitting regulatory submissions such as product registrations and post-market surveillance reports.
• Acting as the primary liaison with regulatory authorities during inspections, audits, and agency interactions.

What You Bring:

We are looking for an accomplished regulatory affairs professional who combines technical expertise with strong business acumen. The ideal candidate will possess:

• A Bachelor's degree in a scientific discipline or engineering (Master’s preferred) with 8–10 years of solid experience in regulatory affairs within the relevant industry.
• Proven success in developing and executing regulatory strategies and obtaining approvals for products across international markets.
• Expertise in both sectors: Medical Devices and Hazardous Substance
• In-depth knowledge of FDA regulations, EU regulations, ISO standards, and other regional requirements.
• Exceptional communication skills to effectively convey complex regulatory concepts to diverse stakeholders.

What's Next?

If you are ready to take your RA to a global stage, please click apply!

Due to the high volume of applications, our team will only be in touch if your application is shortlisted.

Robert Walters Recruitment (Thailand) Limited
Recruitment License No.: น. 1188 / 2551