Labeling Associate Specialist

Labeling Assoc Specialist

1 Year Contract (with high possibilities of extension)

Warsaw, IN

Duties

• Serve as the Global Labeling and Packaging team member for Labeling and packaging development initiatives, including but not limited to NPD (new product development), M&A, CPI (Core product improvement), and UDI tasks.
• Work with Regulatory, Development, Brand, Manufacturing, and other departments to develop/create labeling and packaging that complies with US, EU, and UDI labeling and packaging regulations and requirements, as required.
• Ensures compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
• Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverables for labeling and packaging.
• Complete Destination labeling, eLabeling for all labeling documents such as but not limited to IFU, Surgical Technique, Creating Material specification, and formats for printed IFU.
• Demonstrates medical packaging design and development execution within a multi-disciplinary project team desired with minor guidance.
• Assists/Conducts and owns testing to support project activities with minor guidance.
• Leads design control process related documentation to support projects with guidance.
• Serve as point of contact for Global Labeling and Packaging Development team for M&A sites.
• If needed, travel to other sites to perform onsite activities like requirement gathering, process understanding, or implementation.

Skills

• Broad knowledge and understanding of Product Labeling and Packaging regulations for US and OUS regions.
• Demonstration of strong problem-solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
• Strong ability to build and strengthen relationships with other areas of the organization (i.e., Marketing, Packaging, Development, IT) and other Business Sites.
• Good understanding of medical packaging design and development execution.
• Good understanding of how labeling systems communicate with other business systems.
• Exceptional attention to detail, organization, and multi-tasking skills.
• Understand the overall business environment, the orthopedic industry, and the marketplace.

Education

• Bachelor’s degree in Science or Technical field with 0+ years’ experience in a labeling or relevant capacity.
• Associate degree in Science or Technical field with 4+ years’ experience in a labeling or relevant capacity.
• High School diploma or equivalent required with 6+ years of experience in a labeling or relevant capacity.