Senior Manager, Labeling

EDWARDS LIFESCIENCES (MALAYSIA) SDN. BHD.; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Edwards Lifesciences Malaysia Sdn. Bhd. is seeking a senior labeling leader to drive regulatory labeling initiatives across business units. You will manage a labeling team, oversee documentation, and coordinate cross-functional efforts to ensure compliant labeling changes.

The role emphasizes process improvement, CAPA ownership, and development of a robust talent plan to align with departmental growth in a fast-paced medical devices environment.

Qualifications

• Bachelor's degree in a related field; Master’s preferred.
• Demonstrated track record in people management.
• Experience in labeling within a regulated industry is preferred.

Responsibilities

• Provide labeling leadership and solutions across BUs; oversee labeling team.
• Create standardized documentation and drive process control with quality metrics.
• Lead risk assessment, mitigation, and CAPA activities for labeling.
• Develop talent plans aligned with department growth strategies.
• Initiate root cause investigations and drive labeling operations improvements.
• Develop labeling standards across the BU and report labeling changes.
• Manage cross-functional collaboration to ensure regulatory compliance.
• Support and train stakeholders on labeling changes and new label development.
• Provide timely updates and insights on labeling projects.

Skills

Labeling leadership

People management

Regulatory labeling

Process improvement

Documentation

Cross-functional collaboration

Analytical thinking

Project management

Education

Bachelor's Degree in related field

Master's Degree or equivalent

Tools

Microsoft Office Suite

Job description

EDWARDS LIFESCIENCES (MALAYSIA) SDN. BHD. 4.6 View all jobs

Imagine how your ideas andexpertisecan change a patient’s life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.You’llpartner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Key Responsibilities

• Provide labeling leadership and product solutions to address business needs including leading initiatives across one or more BUs and labeling areas, driving capacity and demand planning for change requests that are aligned with BU-driven prioritization in collaboration with stakeholders. Manage and oversee the work of a Labeling team and may indirectly manage cross functional or matrix teams. Drive labeling design and solution activities for product labels, instructions for use (IFU) and other forms of regulated labeling materials
• Create assigned standardized documentation and processes. Own and lead the execution of process control within assigned scope utilizing quality metrics. Identify opportunities and lead the implementation of changes to drive improvements within assigned BU
• Manage activities with the accountability for successful completion of assigned Labeling deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up in collaboration with stakeholders. Educate, train, and guide stakeholders to provide accurate information in support of successful labeling changes and new label development
• Develop a robust talent development plan in alignment with functional growth strategies of the department
• Initiate root cause investigations for labeling operations driven non-conformances and CAPA investigations and ownership. Develop labeling operations metrics and lead the execution of operations quality initiatives
• Drive standardized solution development and best practices for labeling initiatives, including recommending and leading activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations. Evaluate risks, identify alternatives, and plan cost-effective labeling approaches to resolve critical issues
• Optimize labeling standards across the BU
• Develop reports on demand and forecast labeling changes for BU
• Other incidental duties

Education and Experience

• Bachelor's Degree in in related fieldrelated experience in Labeling Required and
• Demonstrated track record in people management Required
• Master's Degree or equivalent in in related fieldExperience working in a regulated industry Preferred

Additional Skills

• - Proven successful project management leadership skills
• - Proven expertise in Microsoft Office Suite and related tools and systems
• - Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• - Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• - Expert understanding of Labeling procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• - Expert understanding of related aspects of Labeling processes and/or systems
• - Ability to build sustainable relationships of trust through open and collaborative communications
• - Knowledge of financial mechanism that relates to Labeling
• - Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• - Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value to the business
• - Strict attention to detail
• - Ability to interact professionally with all organizational levels and proactively elevate issues to appropriate levels of management in the organization
• - Adherence to quality system, global and regional Labeling standards and regulations Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• - Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
• - Participate and present at meetings with internal and external representatives
• - Resolve operational and scheduling issues
• - Dedicated to quality client service and pro-active and responsive to client needs.
• - Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• - Develop relationships and leverage them to influence change
• - Support and solicit input from team members at all levels within the organization
• - Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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Pharmaceuticals, Biotechnology & Medical Devices More than 10,000 employees

We are a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, we collaborate with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, we have extensive operations in North America, Europe, Japan, Latin America, and Asia and currently employ over 14,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

We are a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, we collaborate with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, we have extensive operations in North America, Europe, Japan, Latin America, and Asia and currently employ over 14,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.