Regulatory Affairs Professional

2 days ago


Singapore Andaman Medical Full time
About the Role

The Regulatory Affairs Specialist at Andaman Medical is responsible for driving regulatory compliance and ensuring that all medical devices meet the necessary regulatory standards. This role requires a strong understanding of regulatory requirements and the ability to communicate effectively with stakeholders.

Main Tasks:
  1. Determine whether a Health Product is a medical device requiring registration with MOH and prepare the necessary documentation.
  2. Submit applications for Initial, Renewal, and Change Notification of medical device submissions and follow up until approval.
  3. Collaborate with manufacturers to ensure successful product registration.
  4. Provide regulatory advice and support to customers.
  5. Develop and maintain a comprehensive regulatory database.
  6. Conduct research and prepare Regulatory Intelligence Reports on various topics.
  7. Stay up-to-date with emerging trends in industry regulations and provide regular updates to the Marketing Manager.
  8. Support the sales team in regulatory-related matters.
  9. Establish and maintain Standard Operating Procedures and regulatory affairs policies and procedures.


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