Job Description

Locations

• USA - California – Irvine

Salary

Skills Required

• device/medical/pharmaceutical FDA regulated industryintermediate
• MS Project preferredintermediate
• MS Office Suiteintermediate

Required Qualifications

• 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 (experience, 5 years)
• 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 (experience, 5 years)

Preferred Qualifications

• Demonstrate strong technical proficiency with the MS Office Suite, with experience using MS Project preferred. (experience)
• Communicate effectively through clear written and verbal communication, strong interpersonal skills, and the ability to negotiate, build relationships, and drive alignment toward shared objectives. (experience)
• Establish and maintain grammatical and formatting standards, templates, and style guides to ensure consistency and quality across labeling deliverables. (experience)
• Exhibit strong leadership and influence, with a demonstrated ability to lead change and drive adoption of improved processes and solutions. (experience)
• Plan, manage, and deliver projects successfully by adhering to schedules, managing dependencies, and maintaining accountability for outcomes. (experience)
• Read, write, comprehend, and speak English fluently to ensure accuracy and clarity in regulated labeling content. (experience)
• Apply a strong understanding of domestic and global labeling development and implementation requirements. (experience)
• Interpret and apply medical and/or pharmaceutical regulations and standards to ensure compliant labeling solutions. (experience)
• Leverage extensive knowledge of medical device documentation development activities throughout the product lifecycle. (experience)
• Work effectively within CR, PLM, and CAPA processes to manage labeling changes and quality events. (experience)
• Demonstrate strong problem-solving capabilities, supported by effective organizational, analytical, and critical thinking skills. (experience)
• Apply solid project management practices to balance scope, timelines, and quality across multiple initiatives. (experience)
• Maintain strict attention to detail in all documentation and execution activities. (experience)
• Interact professionally across all organizational levels, including frequent engagement with senior internal and external stakeholders on complex matters requiring cross organizational coordination. (experience)
• Demonstrate strong technical proficiency with the MS Office Suite, with experience using MS Project preferred. (experience)
• Communicate effectively through clear written and verbal communication, strong interpersonal skills, and the ability to negotiate, build relationships, and drive alignment toward shared objectives. (experience)
• Establish and maintain grammatical and formatting standards, templates, and style guides to ensure consistency and quality across labeling deliverables. (experience)
• Exhibit strong leadership and influence, with a demonstrated ability to lead change and drive adoption of improved processes and solutions. (experience)
• Plan, manage, and deliver projects successfully by adhering to schedules, managing dependencies, and maintaining accountability for outcomes. (experience)
• Read, write, comprehend, and speak English fluently to ensure accuracy and clarity in regulated labeling content. (experience)
• Apply a strong understanding of domestic and global labeling development and implementation requirements. (experience)
• Interpret and apply medical and/or pharmaceutical regulations and standards to ensure compliant labeling solutions. (experience)
• Leverage extensive knowledge of medical device documentation development activities throughout the product lifecycle. (experience)
• Work effectively within CR, PLM, and CAPA processes to manage labeling changes and quality events. (experience)
• Demonstrate strong problem-solving capabilities, supported by effective organizational, analytical, and critical thinking skills. (experience)
• Apply solid project management practices to balance scope, timelines, and quality across multiple initiatives. (experience)
• Maintain strict attention to detail in all documentation and execution activities. (experience)
• Interact professionally across all organizational levels, including frequent engagement with senior internal and external stakeholders on complex matters requiring cross organizational coordination. (experience)
• 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. (experience)

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. 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.
• 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.

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