ภาพรวม

• รายได้ต่อเดือน

  50,000 THB ~ 80,000 THB

• ประเภทธุรกิจ

  Medical

• รายละเอียด

  • Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and route of submission.
  • Preparing and submitting applications for initial registration, 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 company's regulatory database.
  • Prepare regulatory intelligence reports by conducting research on relevant regulatory topics.
  • 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 regulatory compliance is maintained or enhanced.
  • Liaise with external parties on matters relating to medical device regulatory requirements.
  • Report 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 relevant top-management decisions, throughout the establishment and supply chain.