Senior Manager, Labelling (RA/QA) - Medical Device

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

Job summary

Michael Page is seeking a Senior Manager, Labelling in Kuala Lumpur to oversee labeling operations and ensure compliance with industry standards. This permanent role requires expertise in engineering and manufacturing processes, with a focus on alignment across multiple Business Units.

You will standardize labeling documentation, govern labeling processes, and drive continuous improvement while collaborating with regional and global stakeholders in APAC to deliver compliant labeling solutions

Qualifications

• Experience in highly regulated industries such as medical devices, pharmaceuticals, life sciences, or regulated manufacturing environments.
• Working knowledge of FDA, MDR, and other regulatory requirements; experience with labeling changes within a compliance framework.
• Proven ability to collaborate with regional and global stakeholders across APAC and lead process improvement initiatives.

Responsibilities

• Provide strategic leadership for labeling operations and product labeling solutions, aligning with business priorities across BUs.
• Standardize labeling documentation, processes, and governance frameworks; monitor quality metrics and drive continuous improvement.
• Oversee end-to-end execution of labeling deliverables, manage risks, and support labeling updates and new product launches.

Skills

Labeling leadership

Regulatory compliance

Cross-functional collaboration

Process improvement

People management

Job description

The Senior Manager, Labelling will oversee labelling operations and ensure compliance with industry standards within the life science sector. Based in Kuala Lumpur, this permanent role requires expertise in engineering and manufacturing processes.

Client Details

A medical device company based in Kuala Lumpur.

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.

Profile

• 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.

Job 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.