Labeling Change Manager

Position: Labeling Change Manager 
Location: San Diego, CA

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.

Key Responsibilities
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.

Qualifications
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).