Global Labeling Platform Leader

Teleflex

Leinster

Hybrid

EUR 90,000 - 120,000

Full time

14 days+

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Job summary

The Global Labeling Systems Application Manager at Teleflex oversees the Kallik/Veraciti labeling platform across regions, ensuring a validated, compliant, and scalable state within a GxP medical device environment.

Working with Regulatory Affairs, Quality, Supply Chain, Manufacturing and IT, you will drive incident resolution, change control, and continuous improvement, while maintaining audit trails and 21 CFR Part 11 compliance in a multinational setting.

Qualifications

  • Bachelor’s degree in information systems, engineering, life sciences or related field.
  • 5+ years supporting enterprise applications in regulated environments (medical devices, pharma, diagnostics).
  • Hands-on experience with labeling systems, regulated document platforms, PLM or similar tools.
  • Strong understanding of labeling lifecycle concepts: versioning, approvals, traceability.
  • Experience with cross-functional stakeholders and global issue resolution.
  • Proficiency with incident/change management, with audit-ready documentation.
  • Knowledge of EU MDR/IVDR labeling requirements and UDI across markets.
  • Experience with GxP SDLC, CSV, validation documentation.
  • English required; German favorable for European sites.

Responsibilities

  • Provide Tier 2/3 support for the Kallik labeling platform, including incident triage and resolution coordination.
  • Maintain support procedures, troubleshooting guides, and knowledge libraries.
  • Coordinate vendor and internal team escalations, manage licensing and upgrades.

Skills

ITIL processes
Incident management
Change management
GxP systems
English proficiency

Education

Bachelor’s degree in information systems or related

Tools

Kallik/Veraciti platform
SAP integration
Loftware / NiceLabel
SQL basics
CSV/Excel mapping

Job description

The Global Labeling Systems Application Manager at Teleflex oversees the Kallik/Veraciti labeling platform across regions, ensuring a validated, compliant, and scalable state within a GxP medical device environment.

Working with Regulatory Affairs, Quality, Supply Chain, Manufacturing and IT, you will drive incident resolution, change control, and continuous improvement, while maintaining audit trails and 21 CFR Part 11 compliance in a multinational setting.

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