Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Labelling Representative position is a unique career opportunity that could be your next step towards an exciting future.
The Labelling Rep is accountable for ensuring that all work associated with updates or changes to global labelling standards/procedures, training plans and process improvements, routing and approval of assigned labelling deliverables through ECR and PDM processes is carried out in compliance with relevant standards and regulations
Key Responsibilities:
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Execute more complex label change packages (e.g., redlines, ECR generation and processing, compiling documentation, data entry) by ensuring documents conform to established grammatical and formatting conventions, templates and within a specific business unit with minimal supervision. Summarize and capture change intent accurately within quality system (e.g., ECR) in adherence to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
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Update routine procedures and recommend process improvement opportunities
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Evaluate routine risks and provide recommendations to resolve issues.
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Other incidental duties, including working with different suppliers and vendors for accurate execution of labelling component
Education and Experience:
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Associate's Degree (or equivalent) plus 2 years' of related work experience required or Leaving Cert (or equivalent) plus 4 years' of related work experience required
Additional Skills:
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Good computer skills including usage of MS Office Suite
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Good written and verbal communication skills and interpersonal relationship skills
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Good time management and organizational skills
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Able to read, comprehend, write, and speak English
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Good knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labelling operations
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Good knowledge of labelling systems and applications (e.g., ECR and PDM processes)
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Strict attention to detail
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Must be able to work in a team environment, including inter-departmental teams
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Provide feedback in a professional, direct, and tactful manner
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Adhere to all EHS rules and requirements 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
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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
