Edwards Lifesciences Specialist, Labeling in Irvine, California
Execute new global content and packaging/labeling artwork in support of assigned Business Unit for new product launches and base business projects. Accountable for ensuring that all work and deliverables associated with labeling updates or changes adhere to regulatory, in-country and Edwards labeling standards/procedures. Assure that labeling deliverables are complete and on time, meet requirements, and routed for approval and release through the Edwards Quality Management System/s and are in compliance with relevant standards and regulations.
Identify solutions for the Clinical, NPD and Sustaining labeling change request requirements:
Provide definition to the requestor and cross-functional representatives with labeling design requirements while establishing agreement on content, format and artifact (e.g., IFUs, Labels, Implant Cards, and Operations Manuals) solutions for moderately complex labeling change packages.
Review workflow expectations and milestones to achieve results to ensure alignment with business strategy, comply with labeling quality systems and meet customer expectations with ability to reach consensus on priorities and target completion dates.
Identify, evaluate, make recommendations and execute labeling change; request tasks to assure alignment with project solution and requested target dates:
Provide recommendations and regular report out on activities and issues resolution of various business scenarios. Prepare, review and approve labeling intake documentation. Provide guidance to labeling team on identification and execution of typical solutions with accelerate timetables for critical projects.
Develop and maintain timetables for creation of new and revisions to existing labeling content and format in a cost-effective manner. Partner with team members to ensure label change package execution aligns with project deliverables.
Lead sections of process improvement projects and propose solutions. Identify and define gaps, revise verbiage to clarify, improve/enhance and/or correct relevant procedures and provide guidance and training as needed.
Provide support to resolve SCARs, NCRs, non-conformances and CAPAs (e.g., process owners). Apply statistically based data research and analysis methods and techniques to identify root causes and corrective actions.
On time completion of training requirements for this position, assist with knowledge and skill transfer to team members. Assist with creation and maintenance labeling process playbook and provide content and format training for team members and stakeholders.
Evaluate and assess risks, identify options to resolve critical path issues
Other incidental duties
Bachelor's Degree required
Three years of Labeling related experience in a medical/pharmaceutical and/or regulated industry
Good computer skills including usage of MS Office Suite
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to establish grammatical and formatting conventions, templates and style guides
Good leadership skills
Experience managing tasks of projects
Able to read, comprehend, write, and speak English
Moderate understanding of domestic and global development and implementation of labeling
Moderate understanding of medical and/or pharmaceutical regulations and standards
Moderate knowledge of medical device documentation development activities
Knowledge of ECR and PDM processes
Good problem-solving, organizational, analytical and critical thinking skills
Basic project management skills
Strict attention to detail
Ability to build productive internal/external working relationships
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.