Regional Regulatory Affairs Specialist
10 hours ago
- Medical Devices MNC headquartered in Japan
- New regional role covering Asia
- Base salary up to $4,800/month + AWS + VB
We are working with a Medical Devices MNC with its HQ based in Japan. They have a strong vision to provide high quality standards and innovations. With a staff strength of over 20,000 employees in APAC and are well known for multiple therapeutic areas ranging from capital equipment to consumables & implants . Due to expansion in Singapore office, they now have a new headcount to join the team as Regulatory Affairs Specialist.
Responsibilities
Reporting to the Regional RA/QA Manager , you will be responsible for coordinating product registrations and renewals across assigned markets, acting as the main liaison between headquarters, factories, and local regulatory authorities. The position involves preparing and reviewing regulatory documentation , supporting tender submissions, ensuring compliance with evolving regulations, and managing post-market activities such as complaint handling, field safety corrective actions, and recalls. The role also includes implementing Good Distribution Practice for Medical Devices , conducting audits, training teams on regulatory standards, and driving process improvements to enhance speed-to-market and compliance efficiency.
Requirements
The ideal candidate is someone with minimum 2 years of hands-on Regulatory Affairs experience, ideally within the Medical Devices / Life Sciences sector. Local RA talents looking to step up to a Regional role are welcome to apply. You will need to be meticulous and process driven, while constantly stay updated to regulatory changes in the region.
Due to nature of the role, you will be required to work from office (central location) from Monday to Friday .
If you would like to be considered for this opportunity, please apply to the advertisement or forward a copy of your full CV to .
Business Registration Number: W | Licence Number: 25S2778 | EA Registration Number: R1653095
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