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Associate Specialist, Labeling
full-timeMalaysia

Summary

Location

Malaysia

Type

full-time

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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:
• 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 prioritzing 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 assessements to support NCR and CAPA activities

What you'll need (Required):
Bachelor's Degree 1 year years experience of related experience Required and
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
• Good computer skills including usage of MS Office Suite
• 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
• Abilty 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

Other facts

Tech stack
Labeling Requirements,Project Management,Collaboration,Risk Evaluation,Process Improvement,Communication Skills,Attention to Detail,Problem-Solving,Organizational Skills,Analytical Skills,Critical Thinking,Medical Device Knowledge,Regulatory Knowledge,MS Office Suite,Interpersonal Skills,Documentation Development

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.

Team size: 10,001+ employees
LinkedIn: Visit
Industry: Medical Equipment Manufacturing
Founding Year: 1958

What you'll do

  • The Associate Specialist, Labeling will determine labeling requirements and ensure the execution of label change packages meets project deliverables. They will collaborate with stakeholders and participate in process improvement projects.

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Frequently Asked Questions

What does a Associate Specialist, Labeling do at Edwards Lifesciences?

As a Associate Specialist, Labeling at Edwards Lifesciences, you will: the Associate Specialist, Labeling will determine labeling requirements and ensure the execution of label change packages meets project deliverables. They will collaborate with stakeholders and participate in process improvement projects..

Why join Edwards Lifesciences as a Associate Specialist, Labeling?

Edwards Lifesciences is a leading Medical Equipment Manufacturing company.

Is the Associate Specialist, Labeling position at Edwards Lifesciences remote?

The Associate Specialist, Labeling position at Edwards Lifesciences is based in Malaysia, Malaysia. Contact the company through Clera for specific work arrangement details.

How do I apply for the Associate Specialist, Labeling position at Edwards Lifesciences?

You can apply for the Associate Specialist, Labeling position at Edwards Lifesciences directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Edwards Lifesciences on their website.