Labeling Specialist, Global Supply Chain

Edwards Lifesciences•Irvine, CA

7d•$74,000 - $104,000

About The Position

Edwards Lifesciences is a leading global structural heart innovation company focused on improving patient lives. The Global Operations & Quality team plays a central part in ensuring products are delivered to patients with cardiovascular disease. This role involves partnering cross-functionally with manufacturing operations and sales teams to deliver solutions to complex challenges and develop knowledge of the medical device industry. Opportunities within the supply chain include strategic inventory planning, labeling, warehouse management, and material handling, all contributing to patient well-being worldwide.

Requirements

Bachelor's Degree with 3 years of related work experience in a device/medical/pharmaceutical FDA regulated industry or equivalent work experience based on Edward's criteria.

Nice To Haves

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 and influence skills, with a demonstrated ability to lead change and drive adoption of improved processes and solutions.
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
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/external working relationships
Adhere to all company rules and requirements (e.g. 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

Responsibilities

Apply professional expertise and judgment to drive labeling activities and business outcomes.
Identify solutions for Clinical, NPD, and Sustaining labeling change request requirements.
Provide definition to requestors and cross-functional representatives with labeling design requirements, establishing agreement on content, format, and artifact solutions for moderately complex labeling change packages.
Review workflow expectations and milestones to ensure alignment with business strategy, compliance with labeling quality systems, and meeting customer expectations.
Identify, evaluate, make recommendations, and execute labeling change request tasks to align with project solutions and requested target dates.
Provide recommendations and regular reports on activities and issue resolution for various business scenarios.
Prepare, review, and approve labeling intake documentation.
Provide guidance to the labeling team on identification and execution of typical solutions with accelerated timetables for critical projects.
Develop and maintain timetables for the creation of new and revision of existing labeling content and format in a cost-effective manner.
Partner with team members to ensure label change package execution aligns with project deliverables.
Partner with vendors on translation projects, preparing content and coordinating internal and external communications to meet timelines.
Proactively identify translation issues, drive resolution, and manage translation project workflows.
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.
Complete training requirements on time and assist with knowledge and skill transfer to team members.
Assist with the creation and maintenance of a 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.
Perform other incidental duties.