Position: Labeling Change Managerย
Location: San Diego, CA
Experienced Project Manager to lead and execute labeling change projects role manages global labeling updatesโincluding IFUs, packaging, artwork, UDI, and eโlabelingโensuring accuracy, compliance, and timely implementation across a regulated medical device environment.
Key Responsibilities
Manage end-to-end labeling change projects for MMS hardware, software, and accessories.
Develop project plans, timelines, risk assessments, and drive crossโfunctional 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.
Qualifications
Bachelorโs / Master degree in Engineering, Life Sciences, or related field.
3โ5+ 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 crossโfunctional leadership skills.
Preferred
PMP certified or similar certification
Experience with product families (e.g., Alaris, Pyxis).