Sr Labeling Lead
Position Overview
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. Job duties:
- Responsible for end-to-end labeling activities for multiple projects from initiation to product launch.
- Lead cross-functional project teams to develop labels that meet the needs of customers and all regional regulatory requirements.
- Plan and execute label development schedule, ensuring timely delivery of draft labels for submissions and release of finished labels into production.
- Ensure all labeling changes comply with company policies and procedures.
- Collaborate and provide guidance to Labeling Design team to ensure labeling requests are completed accurately and promptly.
- Update project tracker and proactively communicate any delays or scope changes to proper stakeholders.
- Ensure appropriate testing is performed prior to implementation of pre-production printing (e.g., legibility, bar code scanning, content accuracy, language, etc.).
- 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.
- Perform additional duties as assigned.
- Bachelor’s degree or equivalent combination of education and experience.
- Minimum five (5) years of relevant experience in product labeling in medical device field.
- Minimum one (1) year of experience in project management in a related field.
- Ability to design and modify labels, IFUs, and Patient Implant Cards.
- 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.).
- Advanced experience with MS Visio
- Ability to Create, Update and Maintain MS Project GANTT’s
- Excellent written and verbal communication skills.
- Proficient with MS Office applications, including Word, Excel, Outlook, and Teams.
- Strong knowledge of global regulations and guidelines pertaining to labeling.
- Demonstrated ability to understand the implications of label changes on pending and approved labels.
- Ability to present labeling design and implementation strategies to obtain alignment from stakeholders (including upper management).
- Ability to write, review, and approve labeling procedures accurately.
- Ability to translate regulation requirements into practical procedures.
- Demonstrated skills in project management.
- Experience successfully managing multiple projects with the ability to motivate cross-functional teams to complete their assigned tasks.
- Skills in team leadership and development.
- Ability to work effectively and confidently in a team environment.
- Ability to multi-task and prioritize projects to meet deadlines.
- Minimum three (3) years of experience in project management.
- Minimum seven (7) years of relevant experience in product labeling in medical device field.