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Regulatory Affairs Manager, Class IV Medical Devices

Bangkok, Thailand

An exciting opportunity for an experienced Regulatory Affairs professional to join a fast growing global medical device organization in a strategic role covering Thailand and Emerging Asia.

As Regulatory Affairs Manager, you will lead regulatory strategy and execution for Class IV medical devices, managing product registrations, renewals and lifecycle activities. You will work closely with distributors, consultants and internal teams to ensure compliance and timely market access, while acting as a key contact with regulatory authorities.

This is a high impact role requiring strong regulatory expertise, stakeholder management and the ability to operate effectively in a dynamic environment.

Key Responsibilities

Lead regulatory activities for Class IV medical devices across Thailand and Emerging Asia.
Manage product registrations, renewals and compliance processes.
Partner with distributors and consultants to ensure efficient submissions.
Act as the main contact with regulatory authorities.
Support audits and ensure delivery of regulatory objectives.

Qualifications

Experience in regulatory affairs within medical devices, with exposure to Class IV devices.
Strong knowledge of Thailand and Emerging Asia regulatory frameworks.
Excellent communication and stakeholder management skills.
Language fluency in English and Thai is essential due to the markets and countries involved in this role.

Apply now for a further conversation. Shortlisting will conclude by end June 2026.

CEI: R