Senior Representative, Labeling

Reposted 2 Days Ago
Be an Early Applicant
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, MYS
In-Office
Entry level
Healthtech • Pharmaceutical
The Role
The role involves determining labeling requirements, collaborating on labeling projects, managing project timelines, evaluating risks, and participating in process improvements within the medical device industry.
Summary Generated by Built In

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

Skills Required

  • Bachelor's Degree
  • 1 year experience in related field
  • Experience in a medical/pharmaceutical FDA regulated industry

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Retirement Support Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful long‑term value to total compensation.
  • Equity Value & Accessibility An employee stock purchase plan with a discount and look‑back feature, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
  • Leave & Time Off Breadth Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. 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. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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