Our client is a global Medical device manufacturers providing healthcare regulatory consultancy across Asia. Due to their current expansion plan, they are looking for a Senior Regulatory Affairs Executive to join their team, in hopes of developing the current high performing team. They are located in the East area.

Job Responsibilities:

Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
Follow up on submissions and address authority feedback to support successful approvals
Liaise with internal teams and external stakeholders to resolve regulatory queries and support product registration activities
Maintain and update regulatory databases and ensure documentation accuracy and compliance
Develop and maintain SOPs and internal regulatory policies to ensure compliance with regulatory requirements
Conduct regulatory intelligence research and prepare reports on regulatory updates and industry developments
Monitor regulatory changes and assess potential impact on ongoing projects, providing updates to stakeholders
Support sales and commercial teams by providing regulatory advice during client discussions when required
Handle post-market regulatory activities such as adverse event reporting, safety corrective actions, and product recalls
Perform any ad-hoc duties when required.

Requirements:

Min Degree in Life Sciences/ Biotechnology / Chemistry, or related discipline
Min5 years of regulatory affairs experience within medical devices
Strong understanding of regulatory submission processes and compliance frameworks
Familiarity with ISO 13485 and GDPMDS would be advantageous.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

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EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)

Senior Regulatory Affairs Executive / East Area