Global Labeling Systems Application Manager

About Teleflex

Teleflex is a worldwide medical technology provider focused on enhancing health and quality of life. Our vision is to be the most trusted healthcare partner, delivering diverse solutions across anesthesia, emergency medicine, cardiology, radiology, surgical, vascular access, and urology. Our trusted brands include Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™, and Weck™, all driven by innovation and purpose.

Role Overview

The Global Labeling Systems Application Manager will oversee the daily operations, improvements, and user support for Teleflex’s global labeling platform built on Kallik/Veraciti. This position ensures system stability, regulatory compliance, and scalability across multiple regions and manufacturing sites while managing labeling workflows to guarantee accurate, traceable label content updates in a GxP-regulated setting including compliance with EU MDR/IVDR, ISO 13485, and FDA 21 CFR Part 11.

Key Responsibilities

• Deliver Tier 2/3 technical support for the Kallik labeling system, performing incident analysis and managing resolutions.
• Maintain operational support documents such as troubleshooting guides and error logs.
• Coordinate issue escalation with vendors and internal teams, including managing the Kallik/Veraciti vendor relationship and evaluating platform upgrades.
• Support global labeling processes like label creation, versioning, approvals, and releases.
• Configure system components (label definitions, data mappings, user roles, routing logic) following change control procedures.
• Collaborate with Regulatory and Quality teams to ensure compliance with approval workflows, audit trails, and electronic signature controls.
• Maintain validated state documentation and support validation activities within regulated environments.
• Participate in audits and inspections, providing necessary system evidence and ensuring appropriate access controls.
• Gather user requirements for system enhancements, manage backlog prioritization, and oversee user acceptance testing.
• Analyze and recommend improvements to labeling processes to optimize quality and efficiency.
• Support integration and troubleshooting with ERP (SAP ECC/S/4HANA), document management systems, PLM, and shop-floor label execution systems like NiceLabel or Loftware.
• Partner with Master Data teams to resolve data quality impacting label outputs.

Required Qualifications and Experience

• Bachelor's degree in Information Systems, Engineering, Life Sciences, Supply Chain, or related disciplines, or equivalent experience.
• Minimum 5 years’ experience supporting enterprise applications within regulated sectors such as medical devices, pharmaceuticals or diagnostics, with direct involvement in labeling or artwork management systems.
• Hands-on expertise with labeling systems, regulated document platforms, PLM, or similar workflow management tools.
• Thorough understanding of labeling lifecycle concepts including content control, versioning, and traceability.
• Proven ability to collaborate across functions to resolve issues globally.
• Knowledge and application of ITIL or other incident/change management frameworks with documented audit readiness.
• Familiarity with EU MDR/IVDR labeling rules, including UDI, multilingual and market-specific labeling nuances.
• Experience with GxP-compliant software development lifecycle processes including validation documentation (IQ/OQ/PQ).
• English fluency required; German language skills considered a plus for European site interaction.

Specialized Skills

• Experience implementing or managing Kallik/Veraciti systems, including label templates and workflow configurations.
• Proficient with SAP integrations, master data dependency management, and document repository linkages.
• Knowledge of enterprise PLM system interfaces and lifecycle state management.
• Capability with CSV/Excel data mapping, basic SQL querying, and log analysis for troubleshooting purposes.
• Familiarity supporting validated environments, including documentation for SDLC phases, testing, and release governance.
• Understanding of electronic signature and audit trail compliance under regulations like ISO 13485 and FDA 21 CFR Part 11.
• Experience managing multi-language labels, translation workflows, and country-specific label variants.
• Exposure to print-and-apply label execution systems and delineating content management from printing processes.

Additional Information

This position involves approximately 10% travel. Working environment is office-based/professional settings primarily. Teleflex is an equal opportunity employer committed to diversity and inclusion. We welcome applicants regardless of age, gender, ethnicity, disability, or other protected characteristics. Accommodation for applicants requiring support during hiring is available upon request.

Note: Teleflex maintains a strict hiring process and does not entertain unsolicited applications from recruiters or third-party firms.