A leading Medical Device company in Minnesota is in immediate need of a Labeling Consultant to work with them for at least 12 months (potential for a 12-month extension). The Labeling Consultant will need to support the team while working onsite at least 3 days/week in Arden Hills, MN.

The Labeling Consultant will be supporting the Urology Labeling team to ensure labeling content is developed compliant to all applicable procedures. The consultant will develop schedules and ensure labeling deliverables are executed to them while maintaining a high standard of quality. This consultant will be the resident expert and primary point of contact for product literature and labeling.

Top Requirements:

• BS degree minimum
• 5 years of Medical Device industry experience as a Labeling expert
• Strong hands-on experience developing product labeling and literature
• Strong communication skills

Project Scope:

• Coordinate all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, etc.
• Coordinate creation/revision of deliverables from project initiation through completion.
• Assess the scope of each project and works with team members and project management to create labeling plans and secure necessary resources.
• Develop deliverable schedules and establishes 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.
• Manage content changes (and mitigate their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
• Implement product labeling via company’s 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.