Global Labeling Systems Lead (Kallik/Veraciti)

Teleflex

Athlone

On-site

EUR 90,000 - 125,000

Full time

14 days+
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Job summary

Teleflex is seeking a Global Labeling Systems Application Manager to support day-to-day operation, continuous improvement, and user enablement of the Kallik platform across regions. The role ensures the labeling system remains compliant, stable, and scalable, with strong collaboration with Regulatory, Quality, Supply Chain, Manufacturing, Packaging Engineering, and IT.

Responsibilities include incident triage, process configuration, change control, and validation documentation.

Qualifications

  • Bachelor’s degree in information systems, Engineering, Life Sciences, Supply Chain, or related field.
  • 5+ years of experience supporting enterprise applications in regulated environments (medical devices, pharma, diagnostics).
  • Hands on experience supporting labeling systems, regulated document platforms, PLM, or comparable workflow tools.
  • Strong understanding of labeling lifecycle concepts: controlled content, versioning, approvals, and traceability.
  • Experience working with cross functional stakeholders and managing issues through resolution in a global environment.
  • Proficiency with incident/change management practices (ITIL concepts), including documentation and audit-ready evidence.
  • Working knowledge of EU MDR/IVDR labeling requirements including UDI, language/country requirements, and label variant management across markets.
  • Experience with GxP-compliant SDLC including CSV, change impact assessment, and validation documentation.
  • Professional proficiency in English; German language skills advantageous for European manufacturing site engagement.

Responsibilities

  • Provide Tier 2 / Tier 3 functional support for the Kallik labeling platform, including incident triage, root cause analysis, and resolution coordination.
  • Own and maintain support procedures including troubleshooting guides, and known error libraries.
  • Coordinate issue escalation with vendors and internal technical teams, ensuring timely resolution aligned to SLAs.
  • Evaluate new platform capabilities against business requirements and regulatory constraints before adoption.
  • Support global business processes for labeling including label creation, updates, approvals, versioning, and release.
  • Configure and maintain system objects (label definitions, data mappings, user roles, routing/approval logic).
  • Partner with Regulatory/Quality to ensure workflows and system controls support compliant approvals, audit trails, and traceability.
  • Configure and maintain approval workflow routing logic, electronic signature controls, and audit trails within Kallik/Veraciti.
  • Support labeling system activities in regulated environments, including maintaining validated state artifacts and traceability matrices.
  • Gather and translate business needs into user stories for system enhancements and integrations.
  • Execute or coordinate UAT activities: test planning, execution, defect tracking, and signoff.

Education

Bachelor’s degree in information systems, Engineering, Life Sciences, Supply Chain, or related field
5+ years of experience supporting enterprise applications in regulated environments
Hands on experience supporting labeling systems, regulated document platforms, PLM, or comparable workflow tools
Strong understanding of labeling lifecycle concepts: controlled content, versioning, approvals, and traceability
Experience with cross functional stakeholders and issue resolution in a global environment
Proficiency with incident/change management practices (ITIL)
Working knowledge of EU MDR/IVDR labeling requirements including UDI
Experience with GxP-compliant SDLC including CSV, validation documentation
Professional proficiency in English; German advantageous

Tools

Kallik/Veraciti platform
SAP integration touchpoints
NiceLabel/Loftware (print execution)
SAP DMS/ECM, PLM integrations

Job description

Teleflex is seeking a Global Labeling Systems Application Manager to support day-to-day operation, continuous improvement, and user enablement of the Kallik platform across regions. The role ensures the labeling system remains compliant, stable, and scalable, with strong collaboration with Regulatory, Quality, Supply Chain, Manufacturing, Packaging Engineering, and IT.

Responsibilities include incident triage, process configuration, change control, and validation documentation.

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