Hollister Incorporated · 21 hours ago
Sr Labeling Systems Specialist
Libertyville, IL
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $121K/yr
5+ years expHollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. They are seeking a Sr Labeling Systems Specialist responsible for managing Global Labeling systems and processes to ensure compliance with regulatory standards while coaching and developing team members. The role involves overseeing labeling system launches, collaborating with cross-functional teams, and maintaining labeling procedures and requirements.
Health CareManufacturing
Responsibilities
Ensure timely and satisfactory completion of labeling system launches, projects, and initiatives
Deploy Global Labeling System(s) at other Hollister Inc. sites, vendors and suppliers; ensure other labeling systems and processes are set up and running efficiently
Work with IT, Regulatory Affairs, Labeling Team and other cross functional teams globally as needed to develop and launch labeling systems that comply with US, EU and/or ROW regulations. Support and execute validation test scripts, label migration, creation and consolidation of label templates as needed, etc. and support integration with other systems within Hollister
Act as the lead business representative on cross functional teams with IT to lead the use, maintenance, and continuous improvement of GLS and VeevaVault; ensuring labeling systems meet business and functionality requirements
Own and support labeling related CAPAs, label complaints investigations, labeling system regression testing, GLS or Printer Qualifications, etc
Implement and manage qualification and/or validation of labeling systems and equipment necessary for printing labels, graphics, artwork, etc
Responsible for the creation, revision and oversight of labeling system procedures and work instructions
Understand UDI labeling requirements, the process for submitting UDI label data elements to government agencies (US, EU, etc) and maintenance and reporting of UDI elements within labeling
Serve as mentor for Global labeling personnel and project team members, providing labeling system support, training, continuing education and problem-solving assistance for system users (license holders)
Apply advanced knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of increased scope and complexity
Collaborate and coordinate labeling efforts with all Hollister Inc. sites, across time zones, as necessary
For VeevaVault only:
In partnership with IT, maintain licensing requirements for labeling materials in VeevaVault
Serve as records champion for approved labeling materials ensuring retirement or replacement of materials aligns to company records management practices
Run reports on performance of the Veeva process and users
Work independently with minimal direction
Qualification
Required
5-8 years of overall experience
Bachelor degree in computer science or related industry is required
Effective communication skills to provide direction and ensure the completion of Global Labeling systems and initiatives
Strong understanding of how labeling systems communicate with other business systems
Ability to build and strengthen relationships with other areas of the organization (i.e. IT, Regulatory Affairs, Manufacturing, etc) across different locations including vendors (external suppliers, contract manufacturers, etc)
Detail oriented with excellent organizational skills and ability to make informed decisions and work well with others
Exposure to working knowledge of US, EU and ROW labeling requirements for medical devices as well as overall FDA, MDR and UDI regulations
Clear, concise and effective oral and written communication skills are required
Working knowledge of Hollister product, as well as Hollister labeling practices, procedures and systems
Solid, functional understanding of departments' needs, capabilities and system interfaces
Problem-solving skills with ability to analyze all aspects of a situation, identify potential solutions and implement the solution in a timely manner
Experience with labeling and technical data entry
Adaptability
Effective technical Writing
Fluency in English
Preferred
Medical device or other health industry labeling systems experience preferred
Global labeling system software preferred
Printing systems and substrates preferred
Industry certifications desirable
Software experience with Qumas, SAP, PXSmartPrint, Loftware, Veeva, Microscan, etc is desired
Knowledge of printable packaging and labeling substrates and printing systems
Experience with automated platforms for routing and approval of labeling materials (ex: Veeva PromoMats, etc.)
Benefits
Paid time off programs
Peer-to-peer recognition
Health and life insurance
Wellness programs and incentives
Generous retirement savings
Participate in the Hollister Corporate Bonus Plan
Medical
Prescription
Dental
Vision
Spending/savings accounts
Disability
Company paid (parental and caregiver) leaves
Statutory leaves/disability programs
Accident
Life
Wellbeing
Education assistance
Adoption assistance
Voluntary benefit programs
401(k) Retirement Savings Plan
Auto-enrollment
ROTH
Vesting
Safe harbor matching contributions
11 paid holidays
Paid vacation based on length of service and exempt/non-exempt status
Sick days based on statutory requirements and/or exempt/non-exempt status
Education assistance
Adoption assistance benefit programs
Company
Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.
1001-5000 employees
H1B Sponsorship
Hollister Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Abinash Nayak
President and COO
scott holloway
Executive Vice President and Chief Commercial Officer
Recent News
2026-01-20
Digital Music News
2026-01-06
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