Regulatory Affairs Specialist

Salary

50,000 THB ~ 70,000 THB

Industry

Medical

Job Description

• Determine whether the Health Product is a medical device requiring registration with the MOH, and identify its risk classification and route of submission.
• Prepare and submit applications for initial registrations, renewals, and change notifications of medical device submissions, including follow-up until approval.
• Promptly inform the manufacturer if there is any feedback from the authority to ensure successful product registration.
• Communicate with customers in response to their regulatory concerns.
• Maintain the regulatory database for the company.
• Prepare Regulatory Intelligence Reports by carrying out research relating to the regulatory intelligence topic.
• Monitor emerging regulatory trends to determine potential impact on internal projects and draft regulato...