Regulatory Compliance Officer
3 days ago
This position requires a high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The successful candidate will drive best practices in office and administrative management within the organisation to maximize efficiency and growth.
Main Responsibilities:- Investigate whether a Health Product is a medical device requiring registration with MOH, determine its risk classification and route of submission.
- Prepare and submit applications related to Initial, Renewal, Change Notification of medical device submissions, including follow up until approval.
- Promptly inform the manufacturer if there's any feedback from Authority to ensure successful product registration.
- Communicate with customers in response to their regulatory concerns.
- Maintain a regulatory database for the Company.
- Prepare Regulatory Intelligence Reports by conducting thorough research on regulatory intelligence topics.
- Monitor emerging trends regarding industry regulations to determine potential impact on internal projects and provide regulatory updates to the Marketing Manager.
- Assist the sales team in discussions with clients on regulatory-related matters when required.
- Develop and maintain Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure regulatory compliance is maintained or enhanced.
- Liaise with external parties on matters relating to medical device regulatory requirements.
- Report post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
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