Senior Representative, Labeling

Edwards Lifesciences; Kuala Lumpur; Vor Ort; MYR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading medical technology company is seeking a motivated individual to join their Global Supply Chain team. The role involves determining labeling requirements for various projects and ensuring timely execution of label changes. The ideal candidate should have a Bachelor’s Degree and at least one year of related experience, preferably in a regulated medical environment. Strong communication and problem-solving skills are essential, along with a keen attention to detail. Opportunities for process improvement will also be part of this role.

Qualifikationen

• 1 year of related experience.
• Working in a medical/pharmaceutical FDA regulated industry preferred.

Aufgaben

• Determine labeling requirements for routine labeling change packages.
• Collaborate with business unit stakeholders in the development of solutions for labeling projects.
• Participate in process improvement projects.

Kenntnisse

Excellent written and verbal communication skills

Good computer skills including MS Office Suite

Basic problem-solving skills

Attention to detail

Ausbildung

Bachelor’s Degree

Jobbeschreibung

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:

• Determine labeling requirements for routine labeling change packages (e.g., MDRs, sustaining changes label/IFU content, CMS migration) by translating business needs for existing labeling documentation (e.g., IFU, product labeling, operations manual) and prioritizing execution workflow
• Partner with team members to ensure label change package execution meets project deliverables
• Collaborate with business unit stakeholders in the development of solutions for labeling projects
• Follow and maintain timetables for creating new/revised content and labeling in a cost‑effective manner
• Evaluate routine risks and provide recommendations to resolve issues
• Participate in process improvement projects
• Other incidental duties: Participate in risk assessments to support NCR and CAPA activities

What you’ll need (Required):

Bachelor’s Degree, 1 year of related experience.

Working in a medical/pharmaceutical FDA regulated industry (preferred).

What else we look for (Preferred):

• Good computer skills including usage of MS Office Suite
• Excellent written and verbal communication skills and interpersonal relationship skills
• Ability to follow established grammatical and formatting conventions, templates and style guides
• Able to read, comprehend, write, and speak English
• Moderate understanding of domestic development and implementation of labeling
• Basic understanding of medical and/or pharmaceutical regulations and standards
• Basic knowledge of medical device documentation development activities
• Knowledge of ECR and Ignite processes
• Basic problem‑solving, organizational, analytical and critical thinking skills
• Strict attention to detail
• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• Participates in arranging own activities in accomplishing objectives
• Ability to evaluate change package and make decisions on resource consumption
• Contributes to the completion of sections of organizational projects and goals; errors in judgment or failure to achieve results may require some expenditures of resources to rectify
• Ability to build stable working relationships internally
• Develops solutions to a variety of problems of basic scope and complexity
• Participate in process improvements
• 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