Global IT Application Lead - Labelling Systems

About Teleflex

Teleflex Incorporated is a worldwide leader in medical technologies, committed to enhancing health and life quality. We strive to be the most trusted healthcare partner, offering diverse solutions across anesthesia, emergency medicine, interventional cardiology, radiology, surgical, vascular access, and urology fields. Our brands like Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™, and Weck™ reflect a unified dedication to advancing healthcare.

Position Overview

The Global Labeling Systems Application Lead is responsible for the operation, ongoing improvements, and user support of the global labeling platform based on the Kallik/Veraciti system. This role guarantees system stability, compliance, and scalability across various regions, ensuring workflows and integrations facilitate accurate, timely, and traceable label content changes within a GxP-regulated medical device manufacturing setting adhering to EU MDR/IVDR, ISO 13485, and 21 CFR Part 11 standards.

Key Responsibilities

• Deliver Tier 2 and Tier 3 functional support including incident assessment, root cause analysis, and resolution management.
• Maintain support documentation such as troubleshooting procedures and known error databases.
• Manage vendor relationships concerning platform licenses, roadmap, upgrades, and escalations in line with SLAs.
• Support labeling business processes including label creation, updates, approvals, versioning, and release management.
• Configure system components like label definitions, data mapping, user roles, and approval routing, maintaining change control compliance.
• Collaborate with Regulatory and Quality departments to ensure compliant workflows, audit trails, and electronic signature controls.
• Maintain validated state through documentation of requirements, test scripts, and release notes; assist in validations and change impact assessments.
• Participate in audits and inspections, providing evidence for compliance regarding system controls and approvals.
• Translate business needs into precise user stories and requirements for system enhancements and integration efforts.
• Manage test activities including UAT planning, execution, defect tracking, and sign-off.
• Evaluate and troubleshoot integrations with ERP (SAP ECC/S4HANA), document management systems (SAP DMS/ECM), PLM, and shop-floor label execution tools such as NiceLabel and Loftware.
• Work with Master Data teams to address data quality impacting label outputs including units, identifiers, translations, and market-specific attributes.

Qualifications

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, Supply Chain or equivalent experience.
• Over five years of experience supporting enterprise applications within regulated environments such as medical devices, pharmaceuticals, or diagnostics.
• Hands-on expertise with labeling or artwork management systems, regulated document platforms, PLM, or similar workflow tools.
• Comprehensive knowledge of labeling lifecycle including content control, version management, approvals, and traceability.
• Experience collaborating with cross-functional global teams and driving issue resolution.
• Proficient in incident and change management methodologies including ITIL, with a strong emphasis on compliance and audit readiness.
• Familiarity with EU MDR/IVDR labeling requirements, UDI, multi-language label management, and market-specific variant control.
• Practical knowledge of GxP-compliant software development lifecycle processes with relevant validation documentation (IQ/OQ/PQ or similar).
• English proficiency required; German language skills beneficial for European site liaison.

Technical Skills and Other Requirements

• Experience with Kallik/Veraciti platform implementations, including template, label rules, and workflow setup.
• Knowledge of SAP integration points (IDocs/interfaces, master data dependencies, SAP DMS linkages).
• Understanding of enterprise PLM integrations ensuring data and lifecycle alignment across systems.
• Ability to perform data mapping using CSV/Excel, basic SQL querying, and log analysis for troubleshooting.
• Exposure to supporting validated systems with SDLC documentation and governance.
• Familiarity with compliance frameworks involving electronic signatures and audit trails according to ISO 13485 and 21 CFR Part 11.
• Experience managing multi-language translations, label variant control, and print-and-apply/shop floor label execution systems.

Work Environment and Travel

This is primarily an office/professional setting role with approximately 10% travel required.

Diversity and Inclusion

Teleflex is committed to equal opportunity employment and embraces diversity and inclusion as core values. We encourage applicants from all backgrounds and provide accommodations as needed to support the application process.

Additional Information

Teleflex strictly adheres to a formal recruitment process and does not engage with unsolicited agency resumes or third-party recruitment firms. There is no request for payment or equipment purchase during the hiring procedure.