Job scope:
Responsible for coordinating and developing packaging and labeling artwork for new and existing medical device products related to acquisitions, including supporting review, approval, and implementation activities. Collaborates with cross-functional stakeholders to design, update, and maintain product labels and labeling content, ensuring accuracy, visual effectiveness, cost efficiency, and compliance with applicable regulatory requirements, industry standards, and company policies.
Key Responsibilities:
•Coordinate and perform desktop publishing and labeling artwork generation using graphic design skills and knowledge of graphic design principles using computer graphics software (e.g., Adobe InDesign, Adobe Photoshop, Adobe Illustrator)
•Coordinate and create labeling data and formats within the Global Labeling System (GLS).
•Ac Acts as a resource for Acquisition product development teams in creating content for Instructions for Use manuals.
•Responsible for the coordination of translations for labeling and literature using translation vendors.
•Manage content changes and mitigate impacts to schedule and consistency by partnering with teams to ensure accuracy and completeness.
•Responsible for creation of new nd changes to miscellaneous packaging components based on preexisting formats and design.
•Maintain Labeling Graphics filing systems, including paper-based and electronic records.
•Leverage expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.
•Support review and Change Request activities for the approval and release of labeling, literature a,nd other packaging components
•Communicate with outside vendors regarding packaging artwork and proofing.
•Monitor and, when necessary, work with functional and project management to address issues that could negatively impact schedule or quality.
•Foster and improve content consistency across labeling.
•Identify and recommend opportunities to improve labeling processes and procedures.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance with quality requirements.
Required qualifications:
•Bachelor’s degree required.
•Experience using Adobe Creative Suite
•Minimum of 4 years of professional labeling experience
•Experience working within quality systems and change control processes.
•Strong attention to detail and ability to manage multiple priorities in a deadline-driven environment.
•Experience working in methe dical device industry or sia milarly regulated industry
•Experience with medical electrical equipment or similar capital equipment
•Ability to collaborate with cross-functional partners, including Regulatory, Quality, R&D, Manufacturing, and Project Management.
Preferred qualifications:
•Direct technical writing experience
•Proficiency with MS Office and MS Project