Labeling Specialist, Global Supply Chain

Edwards; Irvine (CA); Hybrid; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Labeling Specialist to drive labeling activities across Clinical, NPD and Sustaining programs. You will partner with manufacturing operations and sales to define content and formats for labels, IFUs, and implant cards, ensuring quality and regulatory compliance.

The role requires a Bachelor's Degree with 3 years in a device/medical FDA-regulated setting, strong MS Office skills, and excellent communication.

Qualifications

• Bachelor's Degree with 3 years of related work experience in a device/medical/pharmaceutical FDA regulated industry.
• Equivalent experience based on Edwards criteria may be considered.

Responsibilities

• Drive labeling activities and ensure alignment with milestones and quality systems.
• Coordinate labeling changes for Clinical, NPD and Sustaining projects; define content, format and artifacts.
• Review workflows and timelines to meet business strategy and customer expectations.
• Identify and execute labeling change tasks to align with project solutions and deadlines.
• Provide guidance to labeling teams on typical solutions and accelerate timetables for critical projects.
• Develop timetables for new and revised labeling content and formats.
• Coordinate translation activities with vendors and manage timelines.
• Lead process-improvement projects and define gaps, revise wording, and train team members.
• Provide support to resolve SCARs, NCRs, non-conformances and CAPAs using data-driven methods.
• Assist with labeling process playbooks and knowledge transfer to teammates.
• Evaluate risks and identify options to resolve critical path issues.

Skills

MS Office Suite

Written and verbal communication

Leadership and change management

Project management

English proficiency

Attention to detail

Problem solving

Team collaboration

Education

Bachelor's Degree

FDA-regulated industry experience

Job description

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

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

How you’ll make an impact:

• Apply professional expertise and judgment to drive labeling activities and business outcomes.
• Identify solutions for the Clinical, NPD and Sustaining labeling change request requirements including:
• 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, and Implant Cards) 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.
• 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.
• 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

What you’ll need (Required):

• 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

What else we look for (Preferred):

• 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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $74,000 to $104,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.