Labeling Project Specialist Contractor - Irvine, CA - RQM+

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 client 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.

Requirements:

• 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
• Product labeling experience (preferably in med device or other regulated industry)
• Project management skills
• Collaborator with cross-functional team members to develop labeling content
• Ability to travel up to 15% including some international travel.

PI256901186