Senior Lead Labeling

2 weeks ago

Aliso Viejo, United States MicroVention-Terumo Full time

Senior Labeling Lead


The Senior Labeling Lead will lead project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards. Ensure labels adhere to regional requirements and international standards along with cross-functional input from Marketing, R&D, Regulatory Affairs, and Legal.


Headquarters: Aliso Viejo


What You’ll Be Doing

  1. Responsible for end-to-end labeling activities for multiple projects from initiation to product launch
  2. Lead cross-functional project teams to develop labels that meet the needs of customers and all regional regulatory requirements
  3. Plan and execute label development schedule, ensuring timely delivery of draft labels for submissions and release of finished labels into production
  4. Ensure all labeling changes comply with company policies and procedures
  5. Collaborate and provide guidance to Labeling Design team to ensure labeling requests are completed accurately and promptly
  6. Update project tracker and proactively communicate any delays or scope changes to proper stakeholders
  7. Ensure appropriate testing is performed prior to implementation of pre-production printing (e.g., legibility, bar code scanning, content accuracy, language, etc.)
  8. 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
  9. Perform additional duties as assigned



The Skills/Experience Needed for the Sr Lead, Labeling

  1. Bachelor’s degree or equivalent combination of education and experience
  2. Minimum five (5) years of relevant experience in product labeling in medical device field
  3. Minimum one (1) year of experience in project management in a related field
  4. Ability to design and modify labels, IFUs, and Patient Implant Cards
  5. In depth knowledge of relevant labeling standards (e.g. 21 CFR 801 – Labeling, 21 CFR 820 – Device Labeling, 21 CFR 830 – Unique Device Identification, FDA 89-4203, ISO 15223, CDRH Guidance Document, etc.)
  6. Excellent written and verbal communication skills
  7. Proficient with MS Office applications, including Word, Excel, Outlook, and Teams



How You Will Stand Out from the Crowd:

  1. Strong knowledge of global regulations and guidelines pertaining to labeling
  2. Demonstrated ability to understand the implications of label changes on pending and approved labels
  3. Ability to present labeling design and implementation strategies to obtain alignment from stakeholders (including upper management)
  4. Ability to write, review, and approve labeling procedures accurately
  5. Ability to translate regulation requirements into practical procedures
  6. Demonstrated skills in project management
  7. Experience successfully managing multiple projects with the ability to motivate cross-functional teams to complete their assigned tasks
  8. Skills in team leadership and development
  9. Ability to work effectively and confidently in a team environment
  10. Ability to multi-task and prioritize projects to meet deadlines
  11. Minimum three (3) years of experience in project management
  12. Minimum seven (7) years of relevant experience in product labeling in medical device field


Our Perks

Medical, Dental, Vision, and 401(k) with Company Match, Casual Work Environment, Work/Life Balance, Talent Development Program, On-site Gym/Exercise Room, Employee Referral Program, 15 days of PTO and 15 Paid Holidays per year, Tuition Reimbursement up to $10,000/Year, LinkedIn Learning Courses, and the list goes on.


We're not just a place to work, but a company to build your career

We are an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

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