Labeling Project Specialist Contractor - Irvine, CA

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

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.

12 Month Contract

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.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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