Regulatory Affairs Specialist

Job Summary

We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support medical device registration and compliance across Southeast Asia. The successful candidate will manage regulatory submissions, maintain documentation, and ensure products meet regulatory requirements in key markets.

• Manage end-to-end regulatory registration activities, including product testing, clinical evaluations, quality system assessments, and multi-country submissions.
• Prepare and submit regulatory filings for Singapore and other markets.
• Communicate with regulatory authorities and track submission timelines to ensure timely approvals.
• Maintain accurate and up-to-date regulatory documentation and records.
• Provide guidance to internal teams on regulatory compliance and market entry strategies.
• Monitor updates from national medical device authorities to ensure ongoing compliance.
• Perform other related duties as assigned by the supervisor.

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 2 years of experience in Regulatory Affairs within the medical device industry
  .
• Strong organizational and coordination skills with the ability to multitask effectively.
• High sense of responsibility, initiative, and problem-solving skills.

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Only shortlisted candidates will be contacted for an interview.

EA License No: 24S2188

EA Personnel No: R

EA Personnel Name:
Poh Sook Hooi