Innovation starts from the heart. Edwards Lifesciences i 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 Labeling position is a unique career opportunity that could be your next step towards an exciting future.

Key Responsibilities: Translate business needs and requirements for labeling change packages
• 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

Education and Experience:
Bachelor's Degree 1 year years experience of related experience Required and
working in a medical/pharmaceutical FDA regulated industry Preferred

Additional Skills:
• 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