Regulatory Affairs Specialist เจ้าหน้าที่กำกับดูแลด้านกฎระเบียบ (ประเทศไทย)

Position Summary | รายละเอียดตำแหน่งงาน

The Regulatory Affairs Specialist is responsible for managing license applications, regulatory processes, and compliance activities across the company’s Medical Device and Cosmetic product portfolio. The ideal candidate should be detail-oriented, organized, and comfortable handling regulatory documentation and submissions. Experience with Thailand FDA applications and renewals for Medical Devices and Cosmetics is highly preferred.

Key Responsibilities | หน้าที่และความรับผิดชอบหลัก

• Act as the Designated Person (DP) for the implementation of GDPMD and monitor compliance with Medical Device regulations within the organization in Thailand.

• Ensure compliance with the Medical Device Importation and Sales Quality Management System (QMS).

• Review and control product labels and medical device manuals to ensure compliance with regulatory requirements.

• Manage all Medical Device and Cosmetic licenses, renewals, and related regulatory records.

• Handle Medical Device registrations for all classifications and Cosmetic notifications with the Thailand FDA.

• Prepare and compile product documentation and technical files for regulatory submissions.

• Coordinate with regional teams and regulatory authorities regarding submissions, inquiries, and timelines.

• Work closely with the Finance/Accounts team regarding license payments and regulatory fees.

• Conduct visits to regulatory authorities when required and serve as the main regulatory contact with the Thailand FDA for product registrations, license renewals, and regulatory communications.

• Manage multiple tasks and work effectively under tight deadlines.

• Perform other duties assigned by the Regulatory Affairs Head.

Qualifications & Requirements | คุณสมบัติผู้สมัคร

• Bachelor’s Degree or higher in a relevant field.

• Must be based in Bangkok, Thailand.

• Minimum 2 years of experience in Regulatory Affairs within the Medical Device and/or Cosmetics industry.

• Familiar with Thailand FDA regulations and submission processes.

• Strong organizational skills and attention to detail.

• Excellent interpersonal, communication, and presentation skills.

• Ability to work effectively in a fast-paced environment and manage complex workloads.

• Candidates who are able to start work immediately or within short notice will be given priority.

Reporting Line | สายการบังคับบัญชา

Reporting line: Regional Regulatory Affairs & Compliance Manager – APAC