Regulatory Affairs Specialist - Medical Devices - Toa Payoh
About the Company
Our client is a global leader in medical technology, dedicated to developing innovative solutions that enhance healthcare for providers, physicians, and patients. With a strong focus on quality and compliance, they work to ensure that cutting-edge medical devices reach hospitals and improve patient outcomes across the Asia-Pacific region.
About the Team | Manager
This role is part of the international Regulatory Affairs team, reporting to the Regulatory Affairs leadership and being a part of the Germany-based Regulatory Affairs team. The team oversees and manages medical device approvals across the Asia-Pacific (excluding China, India, Japan, and Korea), working closely with regulatory authorities and internal stakeholders to ensure compliance.
About the Job
As a Regulatory Affairs Specialist, you will be responsible for obtaining medical device approvals across the Asia-Pacific region, including preparing regulatory submissions to health authorities, supporting local partners, and ensuring compliance with relevant laws and regulations.You will maintain regulatory databases, manage medical device licenses, and provide support to internal teams such as Sales, Operations, and R&D. Additionally, you will handle Field Service Notices with local authorities and assist in quality audits.
This role covers SEA countries, Hong Kong, Taiwan, and Australia, with work based in Singapore.
Skills and Experience Required
The ideal candidate will possess:
- A degree in engineering or life sciences (other degrees may be considered).
- A strong interest in quality management and regulatory affairs.
- Experience in ASEAN regulatory affairs or local regulations in the ASPAC market (e.g., Singapore, Malaysia, Thailand, Indonesia) is a plus.
- Excellent attention to detail and the ability to manage multiple projects.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Strong communication skills in English; additional language skills are an advantage.
If you are a detail-oriented regulatory affairs professional looking to contribute to a leading medical technology company, this is your opportunity to make an impact. Apply now to be part of a dynamic team driving innovation in healthcare!
To apply online, please use the 'apply' function. You may contact Putra Nur Afiq (EA: 94C3609/R22105891) directly via email or LinkedIn for more information. We regret to inform you that only shortlisted candidates will be notified.