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Compliance and Registration Manager

1 week ago

Singapore Andaman Medical Full time

Regulatory Affairs Specialist Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. This role is responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.

Key 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.
  • Promptly inform manufacturer if there's any feedback from Authority to ensure successful product registration.
  • Communicate with customers in response to their regulatory concerns.
  • Maintain regulatory database for the Company.
  • 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.

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.