Senior Labeling Specialist

3 weeks ago

Cluain Meala, County Tipperary, Ireland Boston Scientific Gruppe Full time

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  • Author physician and patient medical device product literature deliverables using Adobe InDesign.
  • Manage, organize, and communicate project information and project activities cross-functionally.
  • Represent the Technical Communications function within project core teams.
  • Apply corporate and regulatory medical device Labeling requirements as it pertains to device product literature.
  • Lead medical device literature standards and regulation projects, where a high level of medical device labeling regulation knowledge is required.
  • Work with other technical communicators to organizing Instructions For Use (IFU) and related product literature for to support regulatory submissions, market expansion, and product commercialization targets.
  • Interface cross-functionally within the product development teams to acquire source material for documents and to develop an understanding of BSC Neuromodulation device hardware and software products.
  • Interface with, and participate in the management of, third party translation suppliers to ensure that global product literature content is translated accurate per schedule.

Requirements

  • 5+ years of experience working as a technical communicator creating product labeling literature (IFUs) within the medical device or pharmaceutical industry.
  • Proficient in the use of Adobe InDesign and ability to demonstrate such proficiency.
  • Demonstrated knowledge of Technical Writing principles and ability to demonstrate such proficiency.
  • Demonstrated ability working under the guidance of standard operating procedures governing the development of medical device product labeling.

Preferred Qualifications

  • Bachelor's degree in Scientific and Technical Communications or similar
  • Advanced degree in a health science or a scientific field of study
  • Demonstrated knowledge of the FDA code of federal regulations 21CFR parts 820 and 801, as well as the EU MDR regulations governing medical device labeling.
  • Experience working with medical device labeling translation suppliers, including authoring content for translatability.

Requisition ID:612524

Job Segment: Medical Device, Pharmaceutical, R&D, Technical Writer, Product Development, Healthcare, Science, Research, Technology

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