Senior Manager, Labelling - Medical Device

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

• Provide strategic leadership for labeling operations and product labeling solutions, ensuring alignment with business priorities across multiple Business Units (BUs). Lead cross-functional initiatives, oversee capacity and demand planning for labeling change requests, and guide the development of product labels, Instructions for Use (IFUs), and other regulated labeling materials.
• Establish, standardize, and maintain labeling documentation, processes, and governance frameworks. Monitor process performance through quality metrics and drive continuous improvement initiatives within assigned business areas.
• Manage end-to-end execution of labeling deliverables, ensuring timely completion and compliance. Identify risks, implement mitigation plans, resolve issues, and collaborate with stakeholders to support successful labeling updates and new product launches.
• Build and execute talent development strategies that support departmental growth objectives, employee engagement, and organizational capability enhancement.
• Lead root cause investigations, non-conformance assessments, and CAPA activities related to labeling operations. Develop operational metrics and drive quality-focused initiatives to strengthen compliance and effectiveness.
• Champion best practices and standardized labeling solutions, including process optimization, legacy system improvements, country-specific regulatory requirements, and adherence to labeling standards and regulations.
• Drive harmonization and optimization of labeling standards across business units to improve consistency, efficiency, and compliance.
• Develop demand forecasts and reporting mechanisms to support labeling resource planning and business decision-making.
• Perform additional duties and projects as assigned.

The Successful Applicant

• Experience within highly regulated industries such as medical devices, pharmaceuticals, life sciences, or regulated manufacturing environments.
• Working knowledge of FDA, MDR, and other regulatory requirements, including experience managing product and labeling changes within a compliance-driven framework.
• Proven experience collaborating with regional and global stakeholders across APAC, with a track record of leading process improvement and operational excellence initiatives.
• Exposure to labeling, packaging, regulatory affairs, quality systems, product lifecycle management, or related functions within regulated organizations.
• Strong and engaging people leader with demonstrated success in developing, coaching, and motivating teams, particularly those with varying levels of experience and maturity.
• Strategic thinker who can translate business objectives into practical solutions while maintaining a strong understanding of day-to-day operations.
• Comfortable challenging existing processes, identifying improvement opportunities, and implementing sustainable, scalable solutions.
• Effective stakeholder manager with the ability to build strong partnerships across Regulatory Affairs, Manufacturing, Quality, Supply Chain, and other cross-functional teams.
• Continuous improvement mindset, with a focus on enhancing compliance, operational efficiency, quality, and customer outcomes.
• Strong communicator and influencer capable of driving alignment and accountability across multiple functions and regions.

What's on Offer

• Competitive monthly salary of MYR 18,000 to MYR 20,000.
• Permanent position in the medical device industry.
• Opportunity to work in Kuala Lumpur.