Labeling Specialist, Global Supply Chain

Edwards Lifesciences•Irvine, CA

About The Position

The Labeling Specialist applies professional expertise and judgment to labeling activities and business outcomes at Edwards Lifesciences. The role supports Clinical, new product development, and sustaining labeling change requests by defining design requirements and working with requestors and cross-functional representatives to agree on content, format, and artifacts such as instructions for use, labels, and implant cards. The specialist aligns workflows and milestones with business strategy, labeling quality systems, and customer expectations, and evaluates and executes change-request tasks to meet target dates. The position develops and maintains labeling schedules, prepares and approves intake documentation, coordinates translation projects with vendors, and proactively resolves translation issues. It also contributes to process improvement, procedure updates, training, process playbooks, and support for quality events such as SCARs, NCRs, non-conformances, and CAPAs. The specialist uses data research and analysis to investigate root causes and corrective actions, assesses risks and critical-path issues, and supports knowledge transfer within the team.

Requirements

Bachelor's degree and 3 years of related work experience in a device, medical, or pharmaceutical FDA-regulated industry, or equivalent work experience based on Edwards' criteria.

Nice To Haves

Good computer skills, including use of the MS Office Suite.
Excellent written and verbal communication and interpersonal skills, including negotiation and relationship management.
Ability to establish grammatical and formatting conventions, templates, and style guides.
Good leadership and influence skills, with demonstrated ability to lead change and drive adoption of improved processes and solutions.
Experience managing project tasks.
Ability to read, comprehend, write, and speak English.
Moderate understanding of domestic and global labeling development and implementation.
Moderate understanding of medical and/or pharmaceutical regulations and standards.
Moderate knowledge of medical device documentation development activities.
Ability to work effectively within change-control and quality-management processes to manage labeling changes and quality events.
Good problem-solving, organizational, analytical, and critical-thinking skills.
Good project-management skills.
Strict attention to detail.
Ability to build productive internal and external working relationships.
Ability to adhere to company rules and requirements, including Environmental Health & Safety rules, and take adequate control measures to prevent injuries and pollution and protect the environment.

Responsibilities

Drive labeling activities and business outcomes using professional expertise and judgment.
Define labeling design requirements with requestors and cross-functional representatives, and establish agreement on content, format, and artifacts for moderately complex labeling change packages.
Review workflow expectations and milestones to align work with business strategy, labeling quality systems, and customer expectations; reach consensus on priorities and target completion dates.
Identify, evaluate, recommend, and execute labeling change-request tasks in alignment with project solutions and target dates.
Provide recommendations and regular updates on activities and issue resolution across business scenarios.
Prepare, review, and approve labeling intake documentation.
Guide the labeling team in identifying and executing typical solutions on accelerated timelines for critical projects.
Develop and maintain cost-effective schedules for creating new labeling and revising existing content and formats.
Partner with team members to ensure label change packages align with project deliverables.
Coordinate translation projects with vendors, including preparing content and managing internal and external communications to meet timelines.
Identify translation issues, drive resolution, and manage translation project workflows.
Lead sections of process-improvement projects and propose solutions.
Identify process gaps, revise procedures for clarity and improvement, and provide guidance and training as needed.
Support resolution of SCARs, NCRs, non-conformances, and CAPAs, including work with process owners.
Use statistically based research and analysis methods to identify root causes and corrective actions.
Complete training requirements on time and assist with knowledge and skill transfer to team members.
Help create and maintain the labeling process playbook and provide content and format training to team members and stakeholders.
Evaluate risks and identify options for resolving critical-path issues.
Follow company rules and requirements, including Environmental Health & Safety requirements, and take appropriate measures to prevent injuries and pollution and protect the environment.