Labeling Lead (Temp) in Carrigtohill at Stryker Corporation

掲載日付: 9/25/2019


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Labelling Lead (Temp - EU MDR Project)


Assists in the timely development and completion of clinical reports, summary documents, package inserts and other documents.. May oversee the electronic regulatory submission process. Oversees and provides recommendations for the development of formats and guidelines for documentation.  Ensures effective planning and management of timelines for all aspects of technical documents.  Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for Labelling medical products. Monitors process of any changes in labelling regulations in the US and/or abroad. Reviews labelling change information and ensures that it is supported by the data and consistent with the application.

Your key responsibilities:

Manage processing of medical device Labelling deliverables (IFUs and Labels) to support global labelling needs with focus on label and package artwork design and language translations. Manage related documentation in PLM system.  Review Labelling deliverables for accuracy and quality prior to release. Subject Matter Expert for change control in the PLM system, specifically as it pertains to Labelling and IFUs and generally to be able to provide support to the wider New Product Development team. Provides support to CAD team through generation of 3D CAD models which are used for detailed drawings of finished medical devices, components and assemblies.

  • Manage processing of medical device Labelling content (IFUs and Labels) to support global Labelling requirements
  • Develop product Labelling in compliance to the appropriate governing standards and regulations
  • Review medical Labelling (labels/IFUs) developed by others to ensure they are complete, and content is consistent and properly formatted
  • Provide critical feedback to team members to assure quality of deliverables
  • Procure and manage language translations from external service providers and review for completeness and correct presentation.
  • Keep project managers informed of progress/delays on project deliverables
  • Manage translations via the PLM system
  • Utilize a variety of specialized software to support departmental deliverables (i.e., desktop publishing software, Labelling design software)
  • Ensure correctness of Stryker-related intellectual property Labelling elements for labelling deliverables
  • Exchange information within functional area to resolve and align label/IFU content
  • Understand production methodology for labelling to communicate to production suppliers
  • Initiate and assist with continuous improvement endeavours in functional area
  • Work closely with contract manufacturers on formats for labelling, IFUs and packaging artwork
  • Determine and track metrics associated to team deliverables
  • Utilize change management system for document releases/updates
  • Review change management documentation specific to functional area
  • Windchill SME for change control
  • Support relevant NCs and CAPA’s, monitor their progress and drive through to completion for all action items pertaining to label and/or IFU issues, including problem solving to resolution, root cause analysis and implementation of corrective item.
  • Provide support to R&D, AO and GQO personnel for the generation and maintenance of engineering drawings and specifications for finished products, components, raw materials, sub-assemblies, jigs/fixtures and assembly aids.
  • Will be required to comply with documentation and Computer Aided Design (CAD) procedures for the creation, maintenance and control of all product related documentation including engineering drawings, engineering specifications and graphic artwork.
  • Support internal and external audits as required
  • Will coordinate with other functions and assist in the maintenance/validation of Medical labelling equipment including any additional duties needed to sustain the Business.

What are we looking for?

  • 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.
  • Roles typically require a university degree, or an extensive amount of practical knowledge gained through experience.
  • Job requires an understanding and application of procedures and concepts of own discipline. 
  • The job requires the ability to make judgements based on practice and previous experience. 
  • This job typically requires a degree or equivalent and no experience.

Work From Home: No

Travel Percentage: None