Senior Representative, Labeling

EDWARDS LIFESCIENCES (MALAYSIA) SDN. BHD.; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

Edwards Lifesciences Malaysia Sdn. Bhd. seeks a labeling operations professional to manage complex label change packages and ensure GDP-compliant documentation.

You will work with cross-functional teams across manufacturing and sales to drive accurate data entry and timely change execution. The role requires an Associate’s Degree with 4 years of related experience or a HS Diploma with 6 years, strong MS Office skills, and excellent written and verbal communication.

Qualifications

• Associates degree with 4 years related experience or HS diploma with 6 years related experience.

Responsibilities

• Execute complex label change packages across business units with GDP-compliant documentation.
• Evaluate routine risks and provide recommendations.
• Lead routine process improvements within scope.
• Provide training and coaching to other team members.

Skills

MS Office Suite

English proficiency

Written & verbal communication

Team collaboration

Education

Associate's Degree

High School Diploma

Tools

ECR processes

PDM processes

Job description

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

Imagine how your ideas and expertise can change a patient's life. Our Global Supply Chain team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner 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.

How you will make an impact:

• Execute complex label change packages (e.g., ECO, mass updates, redlines, ECR generation and processing, compiling documentation, data entry) within and across all business units/sites with limited to no direction. Summarize and capture change intent accurately within quality system (e.g., ECR) in adherance to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
• Evaluate routine risks and provide recommendations to resolve issues.
• Update more complex procedures and lead routine process improvement opportunities within scope
• Provide training and coaching to other team members

What you'll need (Required):

• Associate's Degree or equivalent (e.g., 2 years of college coursework) with 4 years of related experience Required or
• H.S. Diploma or equivalent with 6 years of related experience Required

What else we look for (Preferred):

• Good computer skills including usage of MS Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good time management and organizational skills
• Ability to identify process improvement activities
• Able to read, comprehend, write, and speak English
• Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling operations
• Good knowledge of labeling requirements across business units
• Full knowledge of labeling systems and applications (e.g., ECR and PDM processes)
• Strict attention to detail
• Must be able to work in a team environment, including inter-departmental teams and other business units, under general supervision
• Provide feedback in a professional, direct, and tactful manner
• 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

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.