regulatory affairs specialist (medical device-apac).

We are currently looking for a Regulatory Affairs Specialist for one of a Medical Device MNC that specialises with surgical equipment. This position requires your urgent attention.

• Reporting to: Regional RA Manager
• Location: Kuala Lumpur
• Excellent employee compensation and benefits
• Work Type: On-site

the role

• Prepare and support regulatory submissions of medical devices to health authorities, including assisting local partners.
• Monitor and implement new or updated regulations impacting product registration and ensure regulatory databases are current.
• Support internal teams (Sales, Operations, R&D) with regulatory guidance, maintain product registration processes, and participate in quality audits.
• Manage medical device licenses, handle Field Service Notices with authorities, and ensure relevant standards are maintained and updated

the experience

• Degree in engineering or life sciences preferred; other relevant degrees will be considered.
• Demonstrated interest in regulatory affairs and quality management, with experience in APAC regulations being an added advantage.
• Strong multitasking skills and ability to manage several projects simultaneously.

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