Job Description

Work Flexibility: Hybrid or Onsite

Under minimal supervision, develops and maintains labels for medical devices. Collaborates with product subject matter experts to gather and assess labeling content. Executes label format and compiles content using specialized software. Audience for labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements.

Essential Duties & Responsibilities

• Collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.
• Participate in new product label planning meetings and capture requirements using quality system planning documents.
• Design label formats for functional usability by healthcare staff.
• Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system.
• Use desktop publishing software to design labels produced by external suppliers.
• Ensure barcodes pass verification testing.
• Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers.
• As needed, support label translation strategies that satisfy international labeling needs.
• Support multiple concurrent labeling projects for new products, mergers and acquisitions, and label maintenance.
• Review labels for completeness and presentation including labels created by others.
• Contact external suppliers to resolve label output details.
• Manage labels in PLM/CMS system for controlled label releases and revision management.
• Manage work to meet project milestones.
• Inform project managers of relevant aspects of language translation and impact to label design.
• Communicate impact of language translation for alignment with project timelines and cost.
• Initiate/assist with departmental continuous improvement endeavors.
• Collect and track data/metrics associated with projects.
• Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements.
• May assist with regulatory audits.
• Submit reports as requested by manager.

Education & Special Trainings

• Bachelor’s Degree or relevant experience.

Qualifications & Experience

• Previous work experience within a regulated industry.
• Able to apply fundamental and advanced concepts, practices, and procedures related to labels.
• Experience with a rigorous change management process.
• Detail oriented with the ability to manage multiple simultaneous projects.
• Strong organizational and time management practices.
• Able to prioritize and work within schedules.
• Must be able to understand and apply advanced technology applied to technical area.
• Excellent problem solving and analytical ability.
• Interest in language translation and international communication.
• Understanding of impact of language translation to format design.
• Ability to work under pressure in a sometimes fast‐paced environment.
• Highly developed computer skills and able to quickly learn new software.
• Experience working with/entering data into data-driven software.
• Hands-on experience with database compilation labeling systems such as i.e., Prisym preferred.
• Experience with Adobe Illustrator and enterprise CMS system desirable.
• Experience with external service suppliers.
• Experience with regulatory compliance for medical devices or pharmaceutical labeling.

Physical Requirements

• Sedentary work performed in typical office environment.
• Generally, involves sitting most of the time and interfacing with a computer.
• Must be able to view printed and on-screen information to verify accuracy.
• Must be able to communicate through multiple means and technologies.
• Must be able to enter data accurately and efficiently.
• Must be able to use common office equipment.

Mental Requirements

• Commitment to quality and following internal procedures.
• Commitment to exceptional customer service.
• Must be able to manage time, projects, and access project demand.
• Must possess strong interpersonal skills including written and oral communication.
• Must be able to bring tasks through to completion with minimal supervision.
• Ability to analyze and resolve routine software processing issues using independent judgment.
• Ability to manage and track multiple projects.
• Ability to adapt to change if/when priorities shift.
• Must be able to support periodic high-volume workload.
• Ability to calculate fundamental time/cost estimates.

Travel Percentage: 10%