Work Flexibility: Hybrid

18 month FTC hybrid role based in Carrigtwohill, Cork

SUMMARY

As a member of the technical publications team develops and maintains product labels to meet labelling requirements for medical devices. Collaborates with product subject matter experts to gather and assess labelling 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.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. The job requires attention to detail in making evaluative judgements based on the analysis of factual information

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KEY AREAS OF RESPONSIBILITY

Support multiple concurrent labeling projects for new products, mergers and acquisitions, and label maintenance
Participate in new product label planning meetings and capture requirements using quality system planning documents.
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.
Inform Business Units on relevant aspects of the labelling process such as requirements, costs, and timelines.
Design label formats for functional usability by healthcare staff
Use specialised labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system. Perform troubleshooting of electronic files as needed.
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
Ensure labels including translations are executed in an efficient and timely manner through collaboration with an external translation service.
Review labels and IFUs for completeness and presentation including labels created by others
As needed, engage in support activities related to publication of IFUs to eIFU website
Review of regulatory documents to ensure medical device labelling references are correct
Initiate/assist with departmental continuous improvement endeavours.
Track data/metrics associated with functional area.
May assist with internal and external regulatory audits.
Contact external suppliers to resolve label output details.
Manage work to meet project milestones.
Inform project managers of relevant aspects of language translation and impact to label design.
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
Submit reports as requested by manager

QUALIFICATIONS KNOWLEDGE SKILLS

Bachelor’s Degree in Communications, Data Management, Procurement, General Business Management, Regulatory Sciences, or equivalent is required and 3 years equivalent experience in the medical device, pharmaceutical or other highly regulated industry.
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
Excellent written and verbal English communication; knowledge of non-English language could be an asset but is not required

Travel Percentage: 10%

Senior Label Designer

Job Description