Overview

• 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 regulatory updates for the Marketing Manager.
  • Assist the sales team in discussions with clients on regulatory matters when required.
  • Develop and maintain standard operating procedures, local working practices, and regulatory affairs policies to ensure that regulatory compliance is maintained or enhanced.
  • Liaise with external parties on matters relating to medical device regulatory requirements.
  • Carry out reporting of post-marketing activities to the authority, such as mandatory problem reports, field safety corrective actions, recalls, and other required notifications.
  • Ensure awareness of obligations to comply with regulatory and other applicable statutory requirements, and of decisions made by top management throughout the establishment and supply chain.