งาน 1 ตำแหน่ง: งาน หางาน งานระเบียบและการอนุมัติผลิตภัณฑ์ทางการแพทย์

รายละเอียด

• 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.