Senior Regulatory Affairs Specialist (Medical Devices, IS0 13485) - #1163578

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 Specialist 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.

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