Regional Labeling & IFU System Analyst

Job Title

Regional Labeling & IFU System Analyst

• Raynham, Massachusetts, United States
• Warsaw, Indiana, United States
• Palm Beach Gardens, Florida, United States
• West Chester, Pennsylvania, United States

• Oversee all processes associated with the ongoing support of regional label and IFU systems.
• Conduct change request intake and execution, and provide daily system support.
• Identify, develop, and deploy updates to existing label & IFU systems or new systems.
• Translate global customer requirements into specific functional design options for global capabilities.
• Strive towards global process and system harmonization while maintaining compliance with regional and global regulations.
• Proactively respond to emerging regional and global regulations and/or business requirements through content and process updates.
• Communicate business issues or opportunities to next management level.
• Ensure personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Perform additional duties as assigned.

• Bachelor’s degree in Supply Chain, Operations Management, Business Management, Engineering, Analytics, or a related field.
• 5+ years of relevant work experience.
• Labeling, operations and supply chain experience preferred.
• Experience working in a matrix environment across geographies and organizations preferred.
• Experience with in new product development, lifecycle management, manufacturing processes and quality preferred.
• Demonstrated understanding of an end‑to‑end supply chain; medical device knowledge required.
• Understanding of labeling and packaging design requirements preferred.
• Understanding of regulations and standards for labeling preferred.
• Knowledge of validation requirements for medical devices with demonstrated experience preferred.
• Knowledge of validation requirements for software systems with demonstrated experience preferred.
• Proven experience in developing and implementing strategies to drive end‑to‑end processes and efficiencies.
• Ability to follow defined processes and standard operating procedures.
• Attention to detail and a commitment to data accuracy and compliance.
• Change management experience preferred.
• Excellent communication, coping and interpersonal skills, with the ability to motivate and persuade impacted team members, and to prepare communications for project team and management.

• Experience in labeling and supply chain operations.
• Experience working in a matrix environment.
• Experience in new product development and lifecycle management.
• Understanding of medical device supply chain.
• Knowledge of labeling and packaging design.
• Understanding of validation for devices and software.
• Demonstrated end‑to‑end process efficiency implementation.
• Adherence to defined processes and SOPs.
• Detail orientation and data accuracy.
• Change management experience.

• Exposure to supply chain planning systems (e.g., ERP, planning or inventory tools).
• Experience in a regulated or manufacturing environment.
• Interest in continuous improvement or operational excellence methodologies.
• Strong communication skills for cross‑team collaboration.

English proficiency required.

Travel:
Minimal travel (generally