MicroVentionTerumo

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Position Overview

Design, develop and update global labeling documents to include product labels, instructions for use (IFUs), implant cards, specifications and technical documentation. Job duties:
  • Designs, develops and implements changes to new and existing product labels and instructions for use (IFUs).
  • Collaborates with labeling change request initiators to understand requirements, design solutions, timelines and deliverables.
  • Creates data-based labels, static pre-printed labels, IFUs and implant cards using labeling software.
  • Develops standardized and optimized label templates and identifies issues associated with design.
  • Ensures labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures and work instructions.
  • Effectively collaborates with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.
  • Coordinates with suppliers and vendors for outsourced printed products and translated materials.
  • Supports investigations, root cause analysis and corrective action to address labeling non-conformances.
  • Supports labeling initiatives collaborating with individuals from functional groups to provide solutions and meet objectives.
  • Performs other responsibilities as assigned.

Job Details

Job ID 12204BR

Aliso Viejo, California, USA

Salary Range:

$80/hour

    1. Bachelor’s Degree in related field or equivalent experience.
    2. Three (3) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation.
    3. Three (3) years of experience in labeling and digital design software platforms, including labeling database management.
    4. High level of attention to detail and sustained focus.
    5. Project management skills and experience.
    6. Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.
    7. Good problem-solving, organizational, analytical and critical thinking skills.
    8. Ability to work in a cross-functional environment while building positive internal/external working relationships.
    9. Good written and verbal communication skills.
    Desired Qualifications
    1. Extensive knowledge and efficient use of digital labeling design software platforms (e.g., Teklynx Central, Teklynx Codesoft, Adobe Creative Cloud, Illustrator, InDesign and Photoshop).
    2. Moderate knowledge of document management systems (e.g., EtQ Reliance).
    3. Ability to perform minor level tasks in SOLIDWORKS.
    4. Basic knowledge of FDA and global regulations as it relates to labeling requirements and documentation.
    5. Understanding of domestic and global labeling implementation.