Position Overview


INNOVATION STARTS WITH YOU

Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.
Labeling DesignSpecialist
Position Overview
Summary:
Design develop update and proofreads global labeling documents to include product labels, instructions for use (IFUs), implant cards, specifications and technical documentation.
  • Designs, develops and implements and proofreads 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.
  • Uses Labeling software and design platforms to create variable data-based labels, static Pre-Printed Labels, IFUs and Implant Cards.
  • Executes verification activities by proofreading labeling documents against redlined input for accuracy to capture spelling, grammatical, formatting, trademark and barcode errors according to labeling standards.
  • 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 and accuracy verification 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.
  • Required Qualifications
    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

    Additional Information
    • The primary work location for this position is Aliso Viejo, CA (company headquarters)
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.

    Comments
    MicroVention® TERUMO was founded in 1997, employs approximately 2,800 worldwide, and has experienced double-digit revenue growth year-over-year 3 years running. Recognized as one of the “Top Workplaces” in Orange County, California, we have a thriving culture that is innovative, customer-focused, clinically driven, demonstrates a team spirit, and empowers its employees to challenge the status quo. “MicroVention® TERUMO…Innovation Starts with You”.