Regulatory Affairs Advisor

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

Regulatory Submissions & Lifecycle Management

Support the Regulatory Affairs Manager in preparing, submitting, and tracking medical device registrations (Pharma, Vision Care, Surgical) for Malaysia and Singapore.

Manage regulatory lifecycle activities, including variations, renewals, certifications, and post‑market requirements.

Conduct regulatory assessments for new products, labeling changes, and packaging updates.

Quality & Compliance Support

• Assist in maintaining quality documentation, SOPs, and records to ensure GDPMD compliance in Malaysia.
• Support quality activities such as drafting or revising work instructions, handling product recalls, and executing CAPA actions.
• Conduct vigilance activities, including adverse event assessments and preparing reportability documentation.

Promotional & Labeling Review

• Review and approve medical device labeling, artwork, and promotional materials to ensure compliance with local regulatory requirements and internal policies.
• Work with internal teams to ensure all marketing claims comply with regulatory standards.

Operations, Documentation & Coordination

• Maintain accurate regulatory files, submission logs, and audit‑ready documentation.
• Coordinate with internal and external stakeholders—including distributors, consultants, authorities, and global RA/QA teams—to support regulatory execution.

Qualifications

• 1‑3 years of experience in medical device registration with Malaysia's Medical Device Authority (MDA).
• Experience with Singapore HSA regulatory submissions is a strong advantage.
• Good understanding of labeling regulations, promotional compliance, and regulatory frameworks.
• Strong project management, planning, and organisational skills.
• Able to work under pressure, manage timelines, and prioritise tasks effectively.
• Excellent stakeholder engagement and communication skills.
• Professional, adaptable, and proactive working style.

Benefits

• Contract: 1 Year
• Covered medical expenses
• Opportunity to grow within a regional regulatory affairs function supporting Malaysia & Singapore markets.
• Work closely with global and regional teams across RA, Quality, Packaging, and Supply Chain within a leading medical device organisation.
• Gain hands‑on experience in regulatory submissions, product lifecycle management, and GDPMD compliance with access to ongoing training and development programs.

Our client is recognised for its commitment to advancing eye health and overall well‑being. Known for its strong heritage, quality standards, and continuous innovation, the company supports both consumers and healthcare professionals through reliable solutions and a patient‑focused approach. It offers a stable, reputable environment for talent looking to grow within an international healthcare setting.