Edwards Lifesciences
Senior Labeling Specialist
USA - California – Irvine · Senior
Sponsorship not specified$92k-$130kDetected 5 days ago
Data AnalysisComplianceProduct ManagementProject ManagementSupply ChainProcess ImprovementFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingCritical ThinkingMicrosoft OfficeWarehouse Management SystemDemand Planning
About the role
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- Partners with cross functional teams to interpret regulations and ensure compliant implementation in labeling.
Requirements
- Imagine how your ideas and expertise can change a patient's life.
- 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.
- Perform other incidental duties as required.
- What you'll need (Required):
- Apply a strong understanding of domestic and global labeling development and implementation requirements.
Nice to have
- What else we look for (Preferred):
- Demonstrate strong technical proficiency with the MS Office Suite, with experience using MS Project preferred.
Compensation
- For California, the base pay range for this position is $92,000 - $130,000 (highly experienced).
Benefits
- 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
- 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.
- The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
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