Senior Labeling Lead - Strategy, Ops & Quality

Edwards Lifesciences Gruppe; Kuala Lumpur; On-site; MYR 120,000 - 240,000; Full time

Job summary

Edwards Lifesciences is seeking a labeling operations leader to drive design, development, and compliance of product labels and IFUs. You will manage a labeling team, coordinate with cross-functional stakeholders, and implement process improvements in a regulated environment.

The role emphasizes leadership, regulatory understanding, and collaboration with BU teams to ensure timely labeling changes and quality outcomes.

Qualifications

• Bachelor's degree in related field required.
• Demonstrated track record in people management required.
• Experience in labeling in a regulated industry preferred.

Responsibilities

• Provide labeling leadership and drive design/solutions for product labels and IFUs.
• Create and own standardized documentation and process controls.
• Lead risk identification, mitigation strategies and CAPA for labeling operations.
• Develop and implement labeling standards and regulatory-compliant practices.
• Generate labeling change reports and support cross-functional teams.

Job description

Edwards Lifesciences is seeking a labeling operations leader to drive design, development, and compliance of product labels and IFUs. You will manage a labeling team, coordinate with cross-functional stakeholders, and implement process improvements in a regulated environment.

The role emphasizes leadership, regulatory understanding, and collaboration with BU teams to ensure timely labeling changes and quality outcomes.