Global IT Application Lead - Labeling Systems

About Teleflex

Teleflex is a worldwide medical technology provider committed to enhancing health and life quality. We strive to be the most reliable healthcare partner, offering diverse solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgery, vascular access, and urology. Our trusted brands include Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™, and Weck™.

Position Overview

The Global Labeling Systems Application Lead manages the Kallik/Veraciti labeling platform used globally across various manufacturing sites. This role ensures system stability, compliance with regulations such as EU MDR/IVDR, ISO 13485, and 21 CFR Part 11, and supports labeling workflows for accurate, traceable label content changes within a regulated medical device production environment. Collaboration with multiple departments is key to supporting operations, system improvements, and user enablement.

Main Responsibilities

• Provide tier 2/3 support for the Kallik platform including incident management and root cause analysis.
• Maintain support documentation such as troubleshooting procedures and error databases.
• Manage vendor relations including licensing, upgrades, platform roadmap involvement, and SLA adherence.
• Support labeling processes encompassing label creation, approval, versioning, and release.
• Configure system elements (label definitions, data mappings, roles, workflows) under change controls ensuring regulatory compliance.
• Ensure compliance by managing workflows supporting audit trails, electronic signatures, and global standards adherence.
• Maintain validated system documentation and support change impact assessments and validation testing.
• Participate in audits providing required evidence for controls and system access management.
• Handle system enhancements, gather requirements, prioritize backlogs, and coordinate user acceptance testing.
• Troubleshoot and maintain integrations with ERP systems (SAP ECC/S4), document management, PLM, and label execution systems like NiceLabel and Loftware.
• Collaborate with master data teams to resolve data quality issues affecting label outputs.

Required Qualifications and Experience

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, Supply Chain, or related discipline, or equivalent experience.
• Minimum of 5 years supporting enterprise applications in regulated industries such as medical devices or pharmaceuticals with direct experience in labeling or artwork management systems.
• Practical knowledge of labeling lifecycle management including controlled content, approvals, versioning and traceability.
• Experience managing stakeholders and resolving issues globally.
• Familiarity with ITIL-based incident and change management incorporating audit documentation.
• Understanding of EU MDR/IVDR labeling criteria including UDI, language and country-specific compliance, and label variant management.
• Experience with GxP-compliant software development lifecycle and validation documentation.
• English fluency is mandatory; German language skills beneficial for European site interaction.

Specialized Skills

• Hands-on experience with Kallik/Veraciti platform configuration and operations.
• Knowledge of SAP integration points like IDocs, interfaces, and master data linkages.
• Familiar with PLM system integrations and lifecycle synchronization.
• Competence in CSV/Excel mapping, SQL query basics, and log analysis for issue resolution.
• Experience supporting validated GxP systems including UAT and release coordination.
• Understanding compliance standards related to electronic signatures and audit trails.
• Handling multi-language label content and managing translation workflows.
• Experience interfacing with print execution systems ensuring label traceability.

Additional Information

Travel required approximately 10% of the time. Work setting is primarily office/professional environment. Teleflex is an equal opportunity employer dedicated to diversity and inclusivity, seeking to create a workplace that reflects its patient base and communities. Accommodation is available upon request during application. Teleflex strictly prohibits unsolicited agency recruitment fees or demands for upfront payments.