Application Manager, Global Labelling Systems

Teleflex; Morrisville (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Teleflex is hiring a Global Labeling Systems Application Manager to support the day-to-day operation and continuous improvement of the company’s labeling platform built on the Kallik/Veraciti platform. You will ensure stability, compliance, and global scalability across sites, working with Regulatory Affairs, Quality, Supply Chain, Manufacturing, Packaging Engineering, and IT.

The role requires 5+ years in regulated environments, experience with labeling or artwork management, and strong

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, or similar).
• 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.
• 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.
• Manage ongoing vendor relationship with Kallik/Veraciti including license tracking, platform roadmap engagement, upgrade planning, and escalation governance.
• Evaluate new platform capabilities against business requirements and regulatory constraints before adoption.
• Configure and maintain system objects (label definitions, data mappings, user roles, routing/approval logic) respecting change control.
• 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 signatures, and audit trails within Kallik/Veraciti (21 CFR Part 11 compliant).
• Support labeling processes: label creation, updates, approvals, versioning, and release across regions.
• Support and troubleshoot integrations with ERP (SAP ECC/S/4HANA), SAP DMS/ECM, PLM, and label execution systems (NiceLabel/Loftware).
• Assist in Maintaining validated state artifacts (requirements, test scripts, traceability matrices, release notes).
• Contribute to internal/external audits with evidence of controls, access management, and electronic approvals.

Skills

English proficiency

Incident management

Change management

Cross-functional collaboration

GxP compliance awareness

Education

Bachelor’s degree in information systems, engineering, life sciences, supply chain, or related field

Tools

Kallik/Veraciti platform

SAP ECC/S/4HANA

SAP DMS / ECM

NiceLabel / Loftware

CSV/Excel mapping & SQL basics

Job description

Select how often (in days) to receive an alert:

Application Manager, Global Labelling Systems

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

TheGlobal Labeling Systems Application Manager (Kallik/VeracitiPlatform) supportstheday‑to‑dayoperation, continuous improvement, and user enablement of the company’s global labeling solution built on theKallikplatform. This roleensuresthe labeling system is stable, compliant, and scalable across regions, and that labeling workflows and integrations enabletimely,accurate, and traceable label content changes. The roleoperateswithin aGxP-regulated medical device manufacturing environment subject to EU MDR/IVDR, ISO 13485, and 21 CFR Part 11, spanning multiple manufacturing sites. The incumbent will be expected tomaintainvalidatedstate through periods of system and infrastructure change.

Working closely with Regulatory Affairs, Quality, Supply Chain, Manufacturing, Packaging Engineering, and IT, the application manager partners to resolve incidents, implement enhancements,maintainvalidated state documentation, and drive consistent global adoption.

Production Support & Operations

• Provide Tier 2 / Tier 3 functional support for the Kallik labeling platform, including incident triage, root cause analysis, and resolution coordination.
• Own andmaintainsupport procedures including troubleshooting guides , and known error libraries.
• Coordinateissueescalation with vendors and internal technical teams, ensuringtimelyresolution aligned to SLAs. Manage the ongoing vendor relationship with Kallik/Veracitiincludinglicencetracking, platform roadmap engagement, upgrade planning, and escalation governance. Evaluate new platform capabilities against business requirements and regulatory constraints before adoption.

Labeling Process & Configuration Support

• Support global business processes for labeling including label creation, updates, approvals, versioning, and release.
• Configure andmaintainsystem objects as applicable (e.g.label definitions, data mappings, user roles, routing/approval logic), following change control.
• Partner with Regulatory/Quality to ensure workflows and system controls support compliant approvals, audit trails, and traceability. Configure andmaintainapprovalworkflow routing logic, electronic signature controls, and audit trail mechanisms within Kallik/Veraciti, ensuring compliance with 21 CFR Part 11 and applicable regulatory requirements.

Compliance, Validation & Audit Readiness

• Support labeling system activities in regulated environments (e.g., medical devices, pharma), including:
• Maintaining validated state artifacts (e.g., requirements, test scripts, traceability matrices, release notes).
• Supporting change impact assessments, validation testing, and controlled deployment documentation.
• Participate in internal/external audits and inspections, providing evidence for system controls, access management, and electronic approvals where applicable.
• Ensure system access and roles aremaintainedunder least privilege and consistent global standards.

Enhancements & Continuous Improvement

• Gather and translate business needs into user stories/requirements for system enhancements and integrations.
• Support backlog grooming, prioritization discussions, and release planning in partnership with system owner/product owner.
• Execute or coordinate UAT activities: test planning, test execution, defect tracking, and signoff coordination.
• Analyze recurring issues and process bottlenecks; recommend improvements to increase labeling cycle time,right‑first‑timequality, and user experience.

Integrations & Data Dependencies

• Support and troubleshoot integrations between Kallik and enterprise platforms such as:
• ERP (e.g., SAP ECC/S/4HANA)
• Document management repositories (e.g., SAP DMS/ECM)
• PLM or regulatory content sources (as applicable)
• Shop-floor label execution systems (e.g.,NiceLabel/Loftware),define andmaintainthe operational boundary between Kallik content management and print execution, ensuring end-to-end label traceability from artwork approval through to print
• Partner with Master Data teams to resolve data quality issues that impact label output (e.g., UoM, identifiers, country/market attributes, translations).

Training, Communication & Global Adoption

• Communicate release updates, known issues, planned downtime, and best practices to global user communities.

Education / Experience Requirements

• Bachelor’s degree in information systems, Engineering, Life Sciences, Supply Chain, or related field (or equivalent experience).
• 5+ years of experience supporting enterprise applications in regulated environments (medical devices, pharma, diagnostics, or similar), including direct experience with labeling or artwork management systems.
• Hands‑onexperience 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 withcross‑functionalstakeholders and managing issues through resolution in a global environment.
• Proficiencywith incident/change management practices (e.g., 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 withGxP-compliant SDLC including CSV, change impact assessment, and validation documentation (IQ/OQ/PQ or equivalent).
• Professionalproficiencyin Englishrequired;German language skillsadvantageousfor European manufacturing site engagement.

Specialized Skills / Other Requirements

• Experience with Kallik/Veracitiplatform implementations or operations (template management, label rules, workflow configuration).
• Working knowledge of SAP integration touchpoints (IDocs/interfaces, master data dependencies, SAP DMS linkages).
• Working knowledge of enterprise PLM integrations, supporting alignment of interfaces,masterdata, and lifecycle states across connected systems.
• Familiarity with CSV/Excel-based mapping, basic SQL queries, and log analysis for troubleshooting.
• Experience supporting validated systems (e.g.,GxP), including SDLC documentation, UAT, andreleasegovernance.
• Exposure to electronic signatures, audit trails, and compliance frameworks (e.g., ISO 13485, 21 CFR Part 11 concepts).
• Experience supporting multi-language label content, translation management workflows, and country-specific label variant control.
• Exposure to print-and-applyor shop-floor label execution integration (e.g.,NiceLabel,Loftware, or Bartender) and the boundary between content management and execution systems.

TRAVEL REQUIRED: 10 %

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].