The Regional Labeling and IFUSystem Analystis responsible for supporting global supply chain labeling systems and IFUs planning and execution processes.  This includes support necessary to sustain daily regional labeling operations as well as changes driven by new product introductions, continuous improvement initiatives, product transfers and regional regulatory changes. This role offers exposure to integrated supply chain processes and provides a strong foundation for career growth within Supply Chain & Operations.

Key Responsibilities

• Oversee all processes associated with the ongoing support of regional label and IFU systems. This includes change request intake and execution as well as day-to-day system support

• Supports all activities associated with the identification,developmentand deployment of updates to existing label & IFU systems or new label & IFU systems.

• Responsible for understanding global customer requirements and translating those requirements into specific functional design options for global capabilities supported by the technology solution.  

• Strive towards global process and system harmonization whilemaintainingcompliance with regional and global regulations.

• Proactively responds to emerging regional and global regulations and/or business requirements through the execution of content and process updates.

• Responsible for communicating business issues or opportunities to next management level

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

Qualifications

Education

• Bachelor’s degreerequired, preferably in Supply Chain, Operations Management, BusinessManagement, Engineering, Analytics, ora relatedfield.

• 5+ Years of relevant work experience isrequired.

Experience and Skills

Required:

• Labeling,Operations and Supply Chain experience is preferred.

• Experience working in a matrix environment across geographies and organizations is preferred.

• Experience within New Product Development, Lifecyle Management, Manufacturing Processes and Quality is preferred

• Demonstrated understanding of an end-to-end Supply Chain, 

• Medical Device knowledge isrequired

• Understanding Labeling and Packaging design & requirements is preferred. 

• Understanding Regulations and Standards for labeling is preferred.

• Knowledge of validation requirements for Medical Devices withdemonstratedexperience is preferred.

• Knowledge of validation requirements for software systems withdemonstratedexperience is preferred. 

• Proven experience in developing and implementing strategies to drive E2E processes and efficiencies.

• Ability to follow defined processes and standard operating procedures.

• Attention to detail anda commitmentto data accuracy and compliance.

• Change Management experience preferred

• Excellent communication, coping and interpersonal skills to motivate and persuade impacted team members including the ability to make complex issues easy for others to understand and the ability to prepare communications for project team and management are required.  

Preferred:

• Exposure to supply chain planning systems (e.g., ERP,planningor inventory tools).

• Experience working in a regulated or manufacturing environment.

• Interestin continuous improvement or operational excellence methodologies.

• Strong communicationskills and the ability to collaborate across teams.

Other:

• Language: Englishproficiencyrequired.

• Travel: Minimal travel (generally <15%), primarily domestic.

• Certifications: Nonerequired.

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