Medical Device Compliance Specialist

4 days ago


Singapore Andaman Medical Full time

About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.

Main Responsibilities

  • Determine whether the Health Product is a medical device requiring registration with MOH, and 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.
  • Inform manufacturers promptly if there's any feedback from Authority to ensure successful product registration.
  • Respond to customer regulatory concerns.
  • Maintain the Company's regulatory database.
  • Conduct research and prepare Regulatory Intelligence Reports.
  • Monitor emerging trends in industry regulations and provide updates to the Marketing Manager.
  • Support sales teams in discussions with clients on regulatory matters.
  • Develop and maintain Standard Operating Procedures, local working practices, regulatory affairs policies and procedures.
  • Liaise with external parties on medical device regulatory requirements.

Qualifications and Requirements

To be successful in this role, you will need:

  • At least a Bachelor's Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
  • At least 2 years' experience in the medical device industry and especially in regulatory affairs.
  • Good management skills.
  • Fluent English with excellent writing and verbal communication skills.
  • Result-oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities.
  • Computer literate with advanced skills in Microsoft Office (Word, PowerPoint, etc.).
  • Able to operate in a multicultural environment.
  • A high level of autonomy at work, yet with a profound team spirit.


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