Product Manager​/Labeling & Packaging

Overview

The Product Manager will oversee medical device labeling and packaging projects, ensuring compliance with FDA regulations (21 CFR Part 801) and driving efficiency in label and artwork management. This role involves project management, cross-functional collaboration, and execution of label change initiatives tied to product lifecycle and manufacturing changes.

• Create and manage redlines, artwork/label designs, and Change Orders, including vendor coordination and deliverables tracking.
• Lead label change projects as part of broader product design changes, e.g., device updates or manufacturing location changes.
• Execute medical device labeling and packaging redesigns to improve label readability, barcode placement, and manufacturing efficiency.
• Participate in investigations related to labeling errors or packaging defects.
• Manage product lifecycle activities, including initiating and overseeing label change requests.
• Work closely with Labeling & Packaging, Regulatory, Engineering, Purchasing, and Vendor teams to ensure Change Orders meet regulatory and quality standards.
• Manage multiple projects using project management tools: plan development, timeline management, risk and issue tracking, status reporting, and metrics.

• Experience in medical device labeling, packaging, and lifecycle product management.
• Knowledge of FDA device labeling requirements (21 CFR Part 801).
• Strong project management skills with experience in cross-functional collaboration.
• Attention to detail and ability to manage multiple concurrent projects.

In short: This role is a Product Manager specializing in medical device labeling and packaging
, focusing on change management, regulatory compliance, artwork/label design, and cross-functional project execution
.

• Mid-Senior level

• Contract

• Manufacturing and Product Management

• Medical Equipment Manufacturing and Medical Practices