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13 days ago
Edwards·13 days ago
13 days ago

Senior Representative, Labeling

Kuala Lumpur BSC, MalaysiaMid · 5-8 years

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About this role

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

H1B sponsor likely
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