Position : Jr. Labeling Specialist

Location: Irvine, CA, Minnetonka, MN, Arden Hills, MN, or Marlborough, MA (Hybrid)

Job Requirements

A leading Medical Device company is in immediate need of 5 Labeling Project Specialists for a 12-month project that can be based out of any of the following locations: Irvine, CA, Minnetonka, MN, Arden Hills, MN, or Marlborough, MA.

These are hybrid roles, the consultants must work at least 3 days/week onsite.

These roles will support a R&D team with a major integration project.
The Labeling Project Specialist (LPS) plans, manages, and directs the creation/revision of product literature and labeling. The LPS works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures. They develop schedules and ensure labeling deliverables are executed to them while maintaining a high standard of quality. The LPS is the resident expert and primary point of contact for all things related to product literature and labeling.

Responsibilities:

• Responsible for coordination of all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, etc.
• Manage and coordinate creation/revision of deliverables from project initiation through completion.
• Assess the scope of each project and work with team members and project management to create labeling plans.
• Develop deliverable schedules and establish milestones for tracking progress. Ensure on-time completion of deliverables, and communicate project status, challenges, and successes on a regular basis to project and functional management.
• Understand and coordinate/monitor completion of key dependencies from other functions.
• Monitor and, when necessary, work with functional and project management to address issues that could negatively impact schedule or quality.
• Lead cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule.
• Foster and improve content consistency across labeling.
• Facilitate team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer.
• Coordinate desktop publishing and labeling artwork generation.
• Coordinate implementation/release activities of labeling deliverables, including elabeling.
• Manage content changes (and mitigate their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
• Implement product labeling via Document Control System.
• Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.
• Identify and implement opportunities for continuous improvement and innovation.

Qualifications

• Associate degree or bachelor's degree
• 4+ years' work experience in regulated industry
• Medical Device experience
• 2+ years Labeling experience
• Direct labeling or technical writing experience desired
• Medical Electrical Equipment / Capital Equipment experience
• Adobe Suite Creative Suite experience strongly preferred
• MS Office and MS Project experience strongly preferred
• Project Management experience
• NiceLabel, Bartender or similar label design software and database experience preferred
• Scrum and agile methodology experience preferred

Required Skills:

• Product labeling experience (preferably in med device or other regulated industry)
• Project management
• Experience collaborating with cross-functional team members to develop labeling content
• 3 managerial references attached with the resume.
• All reference must include: first name, last name, job title, Linkedin, work email address, and work phone number.
• please make sure to include references, graduation dates

Thanks regards

Manoj Prajapati | Technical Recruiter

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