Edwards Lifesciences

Senior Representative, Labeling

Edwards Lifesciences  •  Malaysia (Onsite)  •  4 hours ago
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Job Description

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

Edwards Lifesciences

About Edwards Lifesciences

Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. 

Contact Us

We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus

If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.

All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.

Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Irvine, CA
Year Founded
1958
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