regulatory affairs executive

Role Overview / 岗位概述

We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our team in Malaysia. The successful candidate will be responsible for managing product registration, liaising with both local and overseas stakeholders, and ensuring compliance with Malaysian regulatory requirements for medical devices as well as other products requiring registration.

我们正在寻找一位积极进取、注重细节的注册事务专员加入我们在马来西亚的团队。该职位将负责管理产品注册,与本地及海外相关方沟通,并确保符合马来西亚医疗器械及其他需注册产品的法规要求。

This role will support the company's operations and business growth by assisting with timely approvals, coordinating with regulatory bodies, and helping to maintain the necessary certifications to operate in Malaysia. The position will work closely with and report to the Singapore office, with guidance provided by the regional team.

该岗位将通过协助及时取得批准、协调监管机构,以及维护公司在马来西亚运营所需的认证,来支持公司的业务运作与发展。该职位将与新加坡办公室紧密合作,并在区域团队的指导下进行工作和汇报。

Key Responsibilities / 主要职责

Manage end-to-end product registration processes and serve as the primary liaison with the Ministry of Health Malaysia (KKM), Medical Device Authority (MDA), and other regulatory bodies to ensure timely approvals for product licensing, company certification, and ongoing regulatory compliance.

负责完整的产品注册流程,并作为主要联络人,与马来西亚卫生部 (KKM)、医疗器械管理局 (MDA) 及其他监管机构沟通,确保及时获得产品许可、公司认证及持续合规。

Coordinate with local and overseas partners to ensure smooth and timely submissions. 与本地及海外合作方协调,确保资料提交顺畅且及时

Ensure all submission documents for product registration are accurate, complete, and fully compliant with regulatory standards; prepare, organize, and maintain documentation for audits, inspections, and licensing purposes.

确保所有产品注册提交文件的准确性、完整性及符合法规标准;负责准备、整理和保存文件,以应对审计、检查及认证要求。

Stay informed on regulatory changes and provide strategic advice to management, while maintaining up-to-date knowledge of compliance requirements across relevant product categories (e.g., medical devices).

及时掌握法规变更,向管理层提供策略性建议,并保持对相关产品类别(如医疗器械)合规要求的最新了解。

Ensure that applicable products are properly registered, notify management of any new competitors, and obtain licenses from relevant authorities as required.

确保相关产品已正确注册,若有新竞争对手及时通知管理层,并按要求取得相关主管部门的许可

Qualifications & Requirements / 任职要求

Preferred candidates will have experience in regulatory affairs, particularly in product registration and compliance with agencies such as KKM and MDA. However, applicants with relevant working experience are also welcome, even without a specific degree in the field. Practical knowledge and hands-on expertise are highly valued.

优先考虑具备注册事务经验的候选人,尤其是在产品注册以及符合 KKM 和 MDA 相关要求方面。有相关工作经验者亦欢迎申请,即使未持有相关学位。我们非常重视实际知识和实操经验。

1–3 years of experience in regulatory affairs, product registration, or compliance in Malaysia, preferably within the medical device sector. 1–3 年马来西亚注册事务、产品注册或合规工作经验,医疗器械领域经验者优先。

Familiar with the regulatory framework for medical devices in Malaysia, including registration processes, compliance requirements, and interactions with authorities such as the MDA. 熟悉马来西亚医疗器械的监管框架,包括注册流程、合规要求,以及与 MDA 等监管机构的沟通。

Familiarity with Good Distribution Practice for Medical Devices (Malaysia) and MedCast licensing. 熟悉 GDPMD 和 Medcast 执照相关流程。

Strong organizational and documentation skills, with exceptional attention to detail, effective time management, and the ability to manage multiple projects efficiently 具备较强的组织与文件管理能力,注重细节,拥有良好的时间管理能力,并能高效管理多个项目。

Excellent communication skills in Mandarin, English, and Bahasa Malaysia. 具备优秀的中英文及马来文沟通能力。

Self-motivated, proactive, and able to work independently. 自我驱动,积极主动,具备独立工作能力。

Good interpersonal skills for engaging with government bodies and business partners. 具备良好的人际交往能力,能够有效与政府机构及业务伙伴沟通合作。