Labelling Specialist - Edwards Lifesciences
  • Limerick, County Limerick, Ireland
  • via ClickaJobs (1)
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Job Description

Job DescriptionEvaluate content to establish standardized labels across product lines and families. Analyze and implement a consistent approach to template and labeling design/execution in a component content management platform.How Will You Make An Impact?Create and execute solutions; includes content and format analysis of existing label designs.Evaluate risk assessment and proposed solutions based on redlines. Identify issues and risks associated with proposed design. Apply technical expertise and perspective to simplify proposed labeling designs. Identify, define and implement process improvements to enhance solutions.Collaborate with Labelling Specialist and change initiator to refine solution requirements, provide innovation and cost-effective design solutions in a timely manner.Develop standard label templates and labeling content with the Global Labelling Systems.Create and updates to related Global Labelling Standards, Procedures, Step guides, and Training materials.Other incidental duties: working with different suppliers and vendors to propose improvement opportunities, organizing label stocks inventory within global labeling team and with suppliers. Provide training and coaching to new labeling designers.What You Will Need?Bachelor's Degree in a related fieldRelated experience in Labeling RequiredAdditional Skills:Experience working in a regulated industry preferredProven successful project management leadership skillsProven expertise in Microsoft Office Suite and related tools and systemsExcellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision makingExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesAbility to listen to the customer’s requirements, desires and concerns, and then determining whether to recommend standardized/harmonized solutions or possibly customizing a path forward, given a variety of problems of moderate scope and complexity.Ability to build productive relationships, influence others and deliver effectively in ambiguous situationsGood leadership skillsExperience managing tasks of projectsModerate understanding of domestic and global development and implementation of labelingModerate understanding of medical and/or pharmaceutical regulations and standardsModerate knowledge of Edwards standards and FDA regulations in relation to labeling and documentationModerate knowledge of medical device documentation development activitiesKnowledge of ECR and PDM processesStrict attention to detailAbility to build productive internal/external working relationshipsAdhere 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. #J-18808-Ljbffr

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