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 >Travel Percentage: 10%
