Senior Labeling Specialist

Regulatory Toolkit; Irvine (CA); In loco; USD 92.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Performance incentives

Benefits package

Descrizione del lavoro

Edwards Lifesciences in Irvine, CA seeks a Senior Labeling Specialist to lead complex labeling projects, collaborate with cross-functional teams, and ensure regulatory compliance across global labeling programs.

You will drive timelines, manage translation work, and mentor labeling staff while aligning with NPD, Clinical, and Sustaining activities in a fast-paced medical device environment.

Competenze

• Bachelor’s degree and 5+ years in FDA-regulated device/medical/pharma industry.
• Experience in labeling processes and regulatory compliance preferred.
• Strong communication and cross-functional coordination abilities.

Mansioni

• Collaborate with Business Units to set priorities and workflow milestones for labeling projects.
• Prepare, review, and approve labeling intake documentation and guide the labeling team on accelerated timelines.
• Ensure updates to global labeling standards, procedures, and training plans.
• Collaborate with vendors on translation projects and manage timelines.
• Provide regular reporting on activities, risks, and issue resolution.
• Lead process improvements and Kaizen initiatives to boost efficiency.
• Lead the resolution of SCARs, NCR, and CAPAs with root-cause analysis.
• Coach BU labeling team members and deliver training and playbooks.
• Understand regulatory requirements and ensure compliant labeling implementations.
• Perform other incidental duties as required.

Conoscenze

Project management

Leadership

Communication skills

English fluency

Regulatory knowledge

Cross-functional collaboration

Formazione

Bachelor's Degree with 5 years of related work experience in a device/medical/pharmaceutical FDA regulated industry

Strumenti

MS Project

MS Office Suite

Descrizione del lavoro

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 Senior 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:

• Collaborate with Business Units to set priorities and workflow milestones (e.g., NPD core team participation, regulatory changes, acquisitions, site transfers) and develop and maintain execution plans with target dates for new or revised content and cost-effective labeling solutions. Provide leadership on alternate strategies to accelerate timelines for critical projects. Lead solution development for labeling projects by recommending activities and solution modifications, guiding requestors and cross functional partners in defining labeling design requirements, and establishing agreement on content, format, and artifacts (e.g., IFU type documents, labels, implant cards) for complex labeling change packages.

• Prepare, review, and approve labeling intake documentation and guide the labeling team on executing standard solutions on accelerated timelines for critical projects. Identify and develop complex solutions to meet Clinical, NPD, and Sustaining labeling change requests and demand planning requirements. Build alignment and consensus on execution plans for complex and high priority labeling change requests, ensuring clarity on solution details and alignment with project plans and deliverables.

• Ensure accountabilities for all updates and changes to global labeling standards, procedures, training plans, and process improvements by routing and approving assigned labeling deliverables through CR and PLM processes in compliance with applicable standards and regulations.

• Collaborate with vendors on translation projects, coordinating internal and external communications to meet timelines. Proactively identify translation issues, drive resolution, and manage translation project workflows.

• Provide recommendations and regular reporting on activities, risks, and issue resolution across various business scenarios.

• Evaluate risks and develop mitigation strategies to resolve critical path issues, while drafting and implementing process improvements that minimize disruption to daily and production activities. Identify and lead process improvement initiatives (e.g., Kaizen) by proposing, implementing, and training teams on new solutions that improve efficiency and effectiveness. Support to collect details for labeling operations metrics and support the execution of operations quality initiatives.

• Lead the resolution of SCARs, NCR, and CAPAs by applying statistically valid data analysis, formal root cause methodologies, and driving effective corrective actions as a process owner.

• Complete all required training on time, coach and develop BU Labeling team members by sharing and transferring knowledge, creating a labeling process playbook, and delivering content and process training to stakeholders.

• Understanding of global regulatory requirements and standards relevant to the business. Partners with cross functional teams to interpret regulations and ensure compliant implementation in labeling. Proactively identifies and mitigates regulatory compliance risks.

• Perform other incidental duties as required.

What you’ll need (Required):

• Bachelor's Degree with 5 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):

• Demonstrate strong technical proficiency with the MS Office Suite, with experience using MS Project preferred.

• Communicate effectively through clear written and verbal communication, strong interpersonal skills, and the ability to negotiate, build relationships, and drive alignment toward shared objectives.

• Establish and maintain grammatical and formatting standards, templates, and style guides to ensure consistency and quality across labeling deliverables.

• Exhibit strong leadership and influence, with a demonstrated ability to lead change and drive adoption of improved processes and solutions.

• Plan, manage, and deliver projects successfully by adhering to schedules, managing dependencies, and maintaining accountability for outcomes.

• Read, write, comprehend, and speak English fluently to ensure accuracy and clarity in regulated labeling content.

• Apply a strong understanding of domestic and global labeling development and implementation requirements.

• Interpret and apply medical and/or pharmaceutical regulations and standards to ensure compliant labeling solutions.

• Leverage extensive knowledge of medical device documentation development activities throughout the product lifecycle.

• Work effectively within CR, PLM, and CAPA processes to manage labeling changes and quality events.

• Demonstrate strong problem-solving capabilities, supported by effective organizational, analytical, and critical thinking skills.

• Apply solid project management practices to balance scope, timelines, and quality across multiple initiatives.

• Maintain strict attention to detail in all documentation and execution activities.

• Interact professionally across all organizational levels, including frequent engagement with senior internal and external stakeholders on complex matters requiring cross organizational coordination.

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 $92,000 - $130,000 (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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.