Senior Labeling Lead, Medical Devices (KL)

Businesslist; Kuala Lumpur; On-site; MYR 201,000 - 223,000; Full time

Benefits offered by this job

Permanent role

KL office

Job summary

Businesslist in Kuala Lumpur seeks an experienced leader to drive strategic labeling operations across multiple business units, ensuring compliance with FDA, MDR, and other regulations while coordinating with regional and global stakeholders in APAC.

The role emphasizes people leadership, process standardization, and continuous improvement to deliver labeling updates and new product launches in a highly regulated environment.

Qualifications

• Experience in highly regulated industries such as medical devices or pharmaceuticals.
• Knowledge of FDA, MDR and regulatory requirements.
• Experience leading regional/global stakeholders across APAC.
• Exposure to labeling, packaging, regulatory affairs, quality systems, product lifecycle management, or related functions within regulated organizations.
• Strong and engaging people leader with coaching and motivating teams.

Responsibilities

• Provide strategic leadership for labeling operations and product labeling solutions aligned with business priorities across multiple BUs.
• Establish, standardize, and maintain labeling documentation, processes, and governance frameworks; monitor quality metrics and drive continuous improvement.
• Manage end-to-end execution of labeling deliverables, identify risks, implement mitigation plans, and collaborate with stakeholders on labeling updates and launches.
• Build and execute talent development strategies to support departmental growth and engagement.
• Lead root cause investigations, CAPA activities, and drive quality-focused initiatives to strengthen compliance.
• Harmonize labeling standards across BUs to improve consistency, efficiency and regulatory adherence.

Skills

Leadership

Stakeholder management

Regulatory compliance

Process improvement

Strategic thinking

People development

Tools

Quality systems

Job description

Businesslist in Kuala Lumpur seeks an experienced leader to drive strategic labeling operations across multiple business units, ensuring compliance with FDA, MDR, and other regulations while coordinating with regional and global stakeholders in APAC.

The role emphasizes people leadership, process standardization, and continuous improvement to deliver labeling updates and new product launches in a highly regulated environment.