Senior Staff Labeling Specialist

We are seeking a detail-oriented and experienced technical Labeling Lead/Specialist to lead our division in the global implementation of a state-of-the-art labeling system. The successful candidate will collaborate with various stakeholders to ensure the system meets user requirements, adheres to regulatory standards, and aligns with corporate strategies. This role is crucial for the successful transfer of products, data migration, and the design and approval of labeling formats.

This is a highly specialized role that requires the application of deep expertise from a professional/ technical thought leader and influences beyond the department. Would engage regularly with Corporate Labeling and IT and support complex technical IT architectural solutions for Labelling. Solutions require advanced technical understanding, process knowledge and awareness of impact on the business.

Key Responsibilities:

• Global Labeling System Implementation:
  • Serve as the primary lead for the division in the implementation of a global labeling system and SAP integration with the labeling system.
  • Develop and implement a label system solution strategy which supports the business product transfer needs and ensures dual manufactured products are supported.
  • Collaborate with Corporate Labeling, Global IT, Operations and product transfer teams to develop a cohesive labeling strategy.
• SAP/ERP integration with the Global Labeling System Implementation:
  • Serve as the primary lead for the division in the SAP/ERP integration with the labeling system.
• User Requirements Analysis:
  • Engage with end-users to gather and define labeling system requirements.
  • Ensure that user needs are clearly documented and communicated to relevant teams.
• Testing and Validation:
  • Write and execute test scripts to validate the labeling system functionality and integration.
  • Ensure the system meets business needs and regulatory market requirements through comprehensive testing.
• Regulatory Compliance:
  • Subject matter expert for the regulatory and Stryker-business requirements for labeling
  • Develop labeling strategies and content based on local and global regulatory requirements and market demands and ensure compliance.
• Cross-Divisional Alignment:
  • Work closely with other divisions and Corporate Labeling to align strategies and requirements for labeling.
  • Facilitate regular meetings and updates to ensure consistent communication and collaboration.
• Process Development
  • Responsible for ensuring compliance to Corporate labeling data governance
  • Develop, document, and implement processes and procedures related to labeling to ensure that products meet customer, market, internal and Corporate Labeling requirements
  • Develops overall strategic plan to improve processes, tools, compliance, training, etc. then leads the strategic program to implement improved processes to reduce error rate in design deliverables, testing and quality documentation.
  • Create training materials and provide training to staff on new labeling processes.
• Product Transfer, Data Migration and Label Design:
  • Lead the labelling activities for the transfer of products from other sites, including the data migration strategy and verification
  • Responsible for new concepts/solutions to optimize labelling content and label format design.
  • Ensure accurate label creation and approval processes are followed.
  • Trains and oversees the work of other labeling specialists.
• Project Management:
  • Lead Global, Divisional or cross functional projects
  • Ability to generate and explain detailed schedules and performance objective
  • Demonstrated experience in presenting to mid-level management

Qualifications:

• Education:
  • Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Experience:
  • Minimum of 4 years of experience in labeling, quality assurance, or regulatory affairs in the medical device industry.
  • Proven experience in project management and cross-functional collaboration.
  • Ability to lead the project labeling team
• Skills:
  • Strong understanding of regulatory requirements related to medical device labeling
  • Excellent communication, analytical and problem-solving skills.
  • Proficient in writing and executing test scripts.
  • Strong communication and interpersonal skills, with the ability to work effectively across departments.
  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Technical Proficiency:
  • Experience with labeling software and systems particularly with Prisym labelling systems (Prisym 360)
  • Experience with data migration processes and tools
  • Key competencies: IT solutioning, information architecture, Project Management, Process management and Quality