Job Description
Job Summary
We are looking for a detail-oriented and proactive Regulatory Affairs Specialist to support the registration and compliance of medical devices across Southeast Asia. The successful candidate will handle submissions, maintain documentation, and ensure adherence to regulatory requirements in key markets.
Key Responsibilities- Manage end-to-end regulatory registration activities, including product testing, clinical evaluations, quality system assessments, and submissions for multi-country market access.
- Prepare and submit regulatory filings for Singapore and other markets.
- Communicate with regulatory authorities and monitor submission timelines to ensure timely approvals.
- Maintain accurate, complete, and up-to-date regulatory documentation and records.
- Provide regulatory guidance to internal teams regarding product compliance and market entry strategies.
- Monitor regulatory updates from national m...