Sr. Specialist, Labeling Design

Terumo Neuro; Los Angeles (CA); On-site; USD 105,000 - 131,000; Full time

Job summary

Terumo Neuro seeks a labeling professional to design, develop, and update global labeling documents including labels, IFUs, patient implant cards, specifications, and technical documentation. The role focuses on continuous improvement of labeling programs and ensuring compliance with QMS and regulatory guidelines.

Responsibilities include investigating labeling non-conformances, collaborating with cross‑functional teams, coordinating with suppliers for printed and translated materials, and

Responsibilities

• Design, develop, and update global labeling documents (labels, IFUs, patient implant cards, specifications, technical docs).
• Develop strategies for continuous improvement of the labeling program and procedures.
• Address labeling non-conformances via investigations and document per the quality system.
• Provide labeling guidance to other teams on implementation processes.
• Design and implement changes to product labels and IFUs using labeling/design software.
• Collaborate with change initiators to understand requirements, timelines, and deliverables; develop templates and identify design issues.
• Ensure labeling compliance with QMS, regulatory requirements, SOPs, and work instructions.
• Coordinate with cross-functional teams to implement labeling designs and changes.
• Coordinate with suppliers for outsourced printed materials and translations.
• Lead investigations, root cause analyses, and corrective actions for labeling non-conformances.
• Assign tasks, mentor labeling team and contractors on workflow, status, and priorities.
• Communicate expected completion dates and meet timelines with minimal supervision.
• Perform other responsibilities as assigned.

Job description

Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, specifications, and technical documentation.

• Develop strategies for continuous improvement of the Labeling program and procedures.
• Conduct investigations and troubleshooting to address labeling non-conformances and document appropriately per the quality system.
• Provide advice or consultancy to other teams with respect to labeling implementation processes.
• Design, develop, and implement changes to new and existing product labels and instructions for use (IFUs) using labeling and design software.
• Collaborate with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables. Develop standardized and optimized label templates and identify issues associated with design.
• Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.
• Effectively collaborate with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.
• Coordinate with suppliers and vendors for outsourced printed products and translated materials.
• Conduct investigations, root cause analyses, and the development of corrective actions to address labeling non-conformances. Lead activities to implement corrective actions.
• Complete labeling initiatives by collaborating with individuals from functional groups and providing solutions to meet objectives.
• Assign tasks and provide guidance, mentoring direction to the labeling group and contractors regarding labeling workflow, project status, and priorities.
• Communicate anticipated assignment completion dates to affected coworkers. Meet timeline commitments with minimal supervision.
• Perform other responsibilities as assigned.

Job ID 14746BR

Salary Range:

$105,067.18-$131,333.98 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)