46878-4808 - Graphic Designer

Unclassified - Santa Rosa, CA

Full-time - Entry Level

Santa Rosa, CA

About the position

The Graphic Designer position is focused on supporting the development of medical device labeling for the Cardiovascular (CV) businesses. This role requires coordination across various functions and multiple US and international sites. The primary responsibilities include managing labeling changes, interfacing with departments such as Marketing, Research and Development (R&D), Regulatory, Technical Communications, Legal, Package Engineering, and site Operations. The Graphic Designer will lead cross-functional collaboration on the scope of changes and labeling requirements, ensuring that all labeling deliverables are completed on time and meet medical, legal, and regulatory requirements for medical devices. In this role, the Graphic Designer will provide project leadership and orchestration of labeling changes, manage projects for labeling-focused initiatives, and provide direction to the internal label development team. They will also develop a labeling plan in accordance with the overall project implementation plan and monitor the labeling development team to ensure timely completion of all deliverables. The position requires a thorough understanding of applicable global labeling regulations and standards, as well as the ability to provide recommendations to improve labeling development processes, quality systems, tools, and policies. Additionally, the Graphic Designer will coordinate the translations of non-IFU labeling through internal or external sources and will be responsible for reviewing product labels, cartons, Instructions for Use (IFUs), and other related materials. This position is heavily focused on coordination of labeling inputs and execution activities, making project management, communication, and multi-tasking essential skills for success.

Responsibilities

• Store and retrieve files as needed for electronic databases of shared information and ensure that content is kept up to date.
• Follow standard guidelines and documented procedures for Master branding, technical labeling, and regulatory requirements in the creation of technical documents.
• Take direction from technical writers, the technical writing manager, or other more senior graphic designers.
• Conduct quality review of materials and processes.
• Attend Technical Communication process and team meetings.
• Provide project leadership and orchestration of labeling changes interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering, and site Operations.
• Lead cross-functional collaboration on the scope of changes and labeling requirements.
• Manage projects for labeling-focused initiatives, as needed.
• Provide direction to the internal label development team.
• Provide inputs and influence overall project implementation plan based on label development requirements and timelines.
• Develop labeling plan in accordance with overall project implementation plan.
• Manage and monitor labeling development team to ensure all labeling deliverables are completed on time.
• Review product labels, cartons, IFUs, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices.
• Manage the review and approval process for all new and revised labeling content.
• Understand applicable global labeling regulations and standards.
• Provide recommendations to the labeling development processes, quality systems, tools, and/or policies.
• Coordinate the translations of non-IFU labeling through internal or external sources.
• Provide input in the creation of and compliance with standards and documented procedures for labeling development, revision, and overall document management.

Requirements

• B.A./B.S. in Packaging, Graphic Design, Marketing, Project Management or related field.
• Minimum of 2 years of experience in a regulated industry in Marketing, Manufacturing, Packaging or related field.
• Experience in working on multi-disciplinary teams.
• Excellent written communication skills.

Nice-to-haves

• M.A./M.S. in Packaging, Graphic Design, Marketing, Project Management or related field.
• Knowledge of US and international medical device regulations and standards, especially those related to labeling.
• Experience working in the medical industry.
• Experience working with global teams.