Regional Regulatory Affairs Advisor – Medical Devices (Malaysia & SG)

Michael Page; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading medical device organization is seeking a Regulatory Affairs professional in Kuala Lumpur to manage regulatory submissions and lifecycle activities for Malaysia and Singapore. The role includes supporting quality documentation, reviewing promotional materials, and coordinating with various stakeholders. Ideal candidates should have 1-3 years of experience in medical device registration, strong project management skills, and an understanding of regulatory frameworks. This 1-year contract offers opportunities for growth within a supportive and reputable environment.

Benefits

Covered medical expenses

Training and development programs

Networking with global teams

Qualifications

• 1-3 years of experience in medical device registration with Malaysia's Medical Device Authority (MDA).
• Strong understanding of labeling regulations and promotional compliance.
• Able to work under pressure and manage timelines effectively.

Responsibilities

• Support the Regulatory Affairs Manager in preparing and tracking medical device registrations.
• Assist in maintaining quality documentation and SOPs for compliance.
• Review and approve medical device labeling and promotional materials.
• Maintain regulatory files, submission logs, and audit-ready documentation.

Skills

Regulatory assessments

Project management

Stakeholder engagement

Organisational skills

Job description

A leading medical device organization is seeking a Regulatory Affairs professional in Kuala Lumpur to manage regulatory submissions and lifecycle activities for Malaysia and Singapore. The role includes supporting quality documentation, reviewing promotional materials, and coordinating with various stakeholders. Ideal candidates should have 1-3 years of experience in medical device registration, strong project management skills, and an understanding of regulatory frameworks. This 1-year contract offers opportunities for growth within a supportive and reputable environment.