Labeling Operations Manager

1 week ago

Aliso Viejo, California, United States MicroVention-Terumo Full time
Job Summary

We are seeking a highly skilled Labeling Lead to join our team at MicroVention-Terumo. As a Labeling Lead, you will play a critical role in supporting project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards.

Key Responsibilities
  1. Labeling Activities: Support labeling activities for multiple projects from initiation to product launch, ensuring timely delivery of draft labels for submissions and release of finished labels into production.
  2. Collaboration: Work alongside cross-functional project teams to develop labels that meet the needs of customers and all regional regulatory requirements.
  3. Label Development: Execute label development schedule, ensuring all labeling changes comply with company policies and procedures.
  4. Labeling Design: Collaborate with Labeling Design team to ensure labeling requests are completed accurately and promptly.
  5. Project Management: Update project tracker and proactively communicate any delays or scope changes to proper stakeholders.
  6. Testing: Ensure appropriate testing is performed prior to implementation of pre-production printing (e.g., legibility, bar code scanning, content accuracy, language, etc.).
  7. Regulatory Compliance: Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  8. Additional Duties: Perform additional duties as assigned.
Requirements
  1. Education: Associate degree or equivalent combination of education and experience.
  2. Experience: Minimum three (3) years of relevant experience in product labeling in medical device field.
  3. Skills: Ability to design and modify labels, IFUs, and Patient Implant Cards, working knowledge of relevant labeling standards (e.g., 21 CFR 801 – Labeling, 21 CFR 820 – Device Labeling, 21 CFR 830 – Unique Device Identification, FDA, ISO 15223, CDRH Guidance Document, etc.).
Preferred Qualifications
  1. Global Regulations: Basic knowledge of global regulations and guidelines pertaining to labeling.
  2. Label Change Implications: Demonstrated ability to understand the implications of label changes on pending and approved labels.
  3. Labeling Design and Implementation: Ability to present labeling design and implementation strategies and obtain alignment from stakeholders.
  4. Regulation Requirements: Ability to translate regulation requirements into practical procedures accurately.
  5. Project Management: Demonstrated skills in project management, experience successfully managing projects with the ability to motivate cross-functional teams to complete their assigned tasks.
  6. Cross-Functional Decision Making: Skills in cross-functional decision making.
  7. Team Environment: Ability to work effectively and confidently in a team environment.
  8. Multi-Tasking: Ability to multi-task and prioritize projects to meet deadlines.
  9. Education: Bachelor's degree in a relevant field of study.
  10. Project Management Experience: Minimum one (1) year of experience in project management.

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