Regulatory Affairs / Government Specialist / Admin (Malaysia)

Responsibilities

• Serve as the primary liaison with the Medical Device Authority (MDA) and other relevant government bodies to facilitate regulatory approvals and maintain positive relationships.
• Manage end-to-end administrative support for medical device registration, including document preparation, translation verification, and submission tracking.
• Handle general government affairs and ad-hoc administrative tasks to ensure smooth local business operations.
• Monitor updates on local regulations and policies, providing timely alerts and practical advice to the management team.
• Coordinate between internal teams and external agencies/vendors to ensure project timelines are met.
• Maintain accurate records of all regulatory filings, licenses, and correspondence with authorities.
• Perform other related duties and special projects as assigned by the supervisor.
• Candidate Requirements:
• Must be able to speak Malay to communicate with local Malaysian authorities.
• Bachelor's Degree in Life Sciences, Public Administration, Business, or a related discipline.
• Minimum of 1-3 years of experience in Regulatory Affairs, Government Relations (GR), or Executive Administration within the healthcare/medical device sector.
• Strong problem-solving skills with the ability to navigate complex bureaucratic processes independently. Highly organized with strong attention to detail and the ability to multitask effectively.

Additional Information

Job Summary: We are looking for a sharp, resourceful, and proactive Regulatory Affairs & Admin Specialist to support our operations in the Malaysian market. The successful candidate will act as our key liaison with the Medical Device Authority (MDA) and handle administrative coordination for medical device compliance. We need a highly organized executor who is culturally fluent and capable of navigating local regulatory and administrative landscapes efficiently.

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