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.

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