Labeling Assoc Specialist

Lancesoft; Warsaw (IN); On-site; USD 52,000 - 72,000; Full time

Job summary

Lancesoft is seeking a Labeling Associate Specialist in Warsaw, IN for a 12-month assignment. You will join the Global Labeling and Packaging team supporting labeling and packaging development for NPD, M&A, CPI and UDI projects, ensuring compliance with US, EU and UDI regulations.

You will coordinate with Regulatory, Development, Brand, Manufacturing and other departments, manage labeling data, releases, and related documentation, and collaborate with external vendors to deliver high-quality

Qualifications

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

Responsibilities

• Serve as Global Labeling and Packaging team member for labeling and packaging development initiatives across US, EU, and UDI projects.
• Ensure compliant labeling creation and data loaded to labeling systems, including approvals, maintenance, and label release.
• Coordinate services with translation, print vendors, and suppliers to deliver high-quality labeling deliverables.
• Complete destination labeling and eLabeling for documents such as IFU and Surgical Technique.
• Lead and support testing, and maintain design control documentation with guidance.

Skills

Labeling regulations

Problem solving

Relationship building

Medical packaging knowledge

Labeling systems knowledge

Attention to detail

Industry knowledge (orthopedics)

Education

Bachelor's degree in Science or Technical field

Associate degree in Science or Technical field

High School diploma or equivalent

Job description

Title

Labeling Assoc Specialist

Location

Warsaw, IN 46580

Duration

12 Months

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 deliverable 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.