Sr Specialist, Labeling Design

Onsite

Aliso Viejo, CA

Hybrid

Aliso Viejo, CA

Remote

Aliso Viejo, CA

Full-Time

Nov 5

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Roles:

Artwork Production

Skills:

Illustrator

Photoshop

InDesign

Job Summary

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

Job Description

Job duties: • 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. Qualifications • Bachelor’s degree in related field or equivalent combination of education and experience. • A minimum of five (5) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation and in labeling and digital design software platforms, including labeling database management. • High level of attention to detail and sustained focus. • Project management skills and experience. • Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases. • Excellent problem-solving, organizational, analytical, and critical thinking skills. • Ability to work in a cross-functional environment while building positive internal/external working relationships. • Excellent written and verbal communication skills. Desired Qualifications • Extensive knowledge and efficient use of Enterprise Label Management software (e.g., Teklynx Codesoft, Loftware Spectrum, PRISYM 360, etc.). Extensive knowledge of Adobe Creative Suite (e.g., Illustrator, InDesign, Photoshop, etc.). • Moderate knowledge of Product Lifecycle Management software (e.g., Windchill, Agile, Teamcenter). • Ability to create CAD drawings and perform intermediate level tasks in SOLIDWORKS. • Knowledge of FDA and global regulations as it relates to labeling requirements and documentation. • Understanding of domestic and global labeling implementation. Posting Country US - United States

Company Description

A global leader in neurovascular innovation, MicroVention is now Terumo Neuro. This name change signifies a new chapter in the company’s evolution while maintaining its unwavering commitment to the creation and commercialization of groundbreaking innovations in neurovascular care. We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neuroendovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in California, Terumo Neuro products are sold in more than seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California, and San José, Costa Rica.

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