Regulatory Affairs Specialist (International Medical Device Registration Head / Medical Device Registration Engineer)

About the role

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 medical device agencies to ensure ongoing compliance. Perform other related duties as assigned by the supervisor. Candidate Requirements: Bachelor's Degree in Life Sciences, Engineering, or related discipline. Minimum of 1-3 years of experience in Regulatory Affairs within medical device industry. Excellent verbal and written communication skills in English. Proficiency in other languages is a strong plus. Strong organizational, coordination, and communication skills, with the ability to multitask effectively. Strong sense of responsibility, initiative, and efficient problem-solving skills.

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