Project Manager - Labeling Change Projects

We are seeking an experienced Project Manager to lead and execute labeling change projects role manages global labeling updates-including IFUs, packaging, artwork, UDI, and e-labeling-ensuring accuracy, compliance, and timely implementation across a regulated medical device environment., * Manage end-to-end labeling change projects for MMS hardware, software, and accessories.

• Develop project plans, timelines, risk assessments, and drive cross-functional alignment.
• Coordinate with Regulatory, Quality, R&D, Supply Chain, and Artwork teams.
• Oversee creation, review, translation, and release of updated labeling assets.
• Ensure compliance with FDA, EU MDR, ISO 13485, and labeling standards.
• Track project progress, manage documentation, and support audit readiness.
• Drive process improvements to streamline labeling workflows.

• Bachelor’s / Master degree in Engineering, Life Sciences, or related field.
• 3-5+ years of experience in medical devices, pharma, or other regulated industries.
• Experience managing labeling or product change control projects.
• Knowledge of FDA labeling requirements, EU MDR, and global UDI standards.
• Experience with PLM/document control systems (SAP and Teamcenter is preferable).
• Excellent communication and cross-functional leadership skills.

Preferred

• PMP certified or similar certification
• Experience with product families (e.g., Alaris, Pyxis).