Regulatory Labeling Specialist

12-Month+ Contract | 1st Shift | Monday-Friday, 8:00 AM-5:00 PM 

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Regulatory Labeling Specialist for a 6 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Assists in the timely development and completion of helping compile, maintain, and review labeling documentation, including drawings, change orders, and specifications, ensuring accuracy and compliance with GMP and QSR standards. This includes developing labeling designs using standard templates and style guides. The role helps to manage digital and hardcopy records (as needed) in the document control systems, resolves discrepancies, and verifies that labeling changes are supported by data and are consistent with applications.
 
 The role requires close collaboration with R&D, R&D Packaging Engineers, Legal, Product Marketing, Regulatory Affairs, Design Assurance, Quality, Manufacturing, and Operations to support customer satisfaction and patient safety.

 Responsibilities

• Support setup of labeling design (new or changes) using the Stryker Neurovascular labeling system and software tools (GLS/Prisym, Adobe Products, Microsoft Office, etc.).
• Use onsite label printers (e.g., Zebra), barcode grader, or other equipment (as needed) as part of the label setup for new or changed labels.
• Troubleshoot printer issues (as needed)
• Support for labeling verification procedures and collaboration with Operations (as needed) to implement labeling in production.
• Actively participate in project team meetings. Coordinate and monitor project task execution and project progress against deliverables.
• Uphold the Quality Policy by maintaining compliance with all quality requirements and supporting process improvements for easier compliance.
• Support updates to technical documentation (SOPs, Work Instructions, technical literature, engineering work products) that is accurate, consistent in style, and appropriate for the intended audience.
• Review and ensure accuracy of other technical publications and labeling, maintaining strong attention to detail and zero documentation escapes.
• Maintain documentation compliance using site-specific data management systems (i.e., PLM).
• Participate in problem-solving initiatives to address technical issues and document resolutions within the quality system.
• Support updates to departmental and quality system SOPs, Work Instructions, forms, and templates with graphical content, and provide input for training and communication materials.
• Work cooperatively with other functional groups and project managers to coordinate labeling review and approvals.

Qualifications 

• Label experience / Experience with label creation software (ex: Prism, Label Creator, Bartender, Nice Label, Easy Label, etc) -- (in a medical device industry, preferred)
• Strong attention to detail and organizational skills.
• Ability to follow detailed procedures and guidelines.
• Medical device industry experience 
• Experience working with label printers (Zebra) 
• Adobe Suite experience (InDesign, PhotoShop, Illustrator, etc) 
• Experience with CAD, SolidWorks
• Bachelor's degree required