Job Title:  Regulatory Affairs Executive

Short Description

Job Purpose:

The Executive – RA is responsible for ensuring that all medical devices comply with applicable regulatory requirements and standards in Thailand. This role will prepare and submit the regulatory applications, communicate with relevant authorities, and collaborate with departments to ensure product compliance and market access.

Job Responsibilities:

1. Ensure medical devices comply with all applicable regulatory requirements and standards
2. Prepare and submit the regulatory dossiers to relevant authorities
3. Communicate with regulatory authorities to respond to inquiries
4. Collaborate with cross-functional teams to execute product strategies (e.g. sales, marketing, and supply chain, etc.)
5. Monitor and stay up-to-date on changes in medical device regulations
6. Maintain thorough documentation and records to demonstrate regulatory compliance
7. Other duties as assigned by supervisor

Job Requirements:

1. Bachelor’s degree in a relevant field such as Life Sciences, Engineering, or similar.
2. A minimum of 2 years’ experience in regulatory affairs, with a focus on advertisement applications, preferably within the medical device or pharmaceutical industry.
3. Having experience in submitting the product registration to other regulatory authorities is an advantage.
4. Understand the regulatory requirements and quality assurance processes will be a plus.
5. Proficient in both written and spoken English.
6. Good knowledge of Microsoft Office (Word, Excel, Adobe, Power Point)
7. Attention to detail