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Principal Technical Writer
Maple Grove, Minnesota  |  Remote
Contract Position
It appears that you have already applied to this job.
Applied on October 18, 2021
Job Id #51304 Posted October 12, 2021


Job Description:

  • Create and author Instructions For Use that support the BSC Neuromodulation division’s medical device product lines.

Responsibilities

  •  Co-author or contribute to the creation and revision of medical device labeling deliverables.
  •  Clearly and correctly state and summarize technical information and conclusions in documents.
  •  Manage, organize, and communicate project information and project activities.
  •  Apply corporate and regulatory documentation requirements.
  •  Lead teams of technical writers with regard to organizing Instructions for Use content for regulatory submissions.
  •  Participate in or lead technical communication projects.
  •  Create and maintain technical communication project schedules, driving milestones to completion.
  •  Interface cross-functionally within the product development team to acquire source material for documents and to develop understanding of the products and processes.
  •  Make suggestions or corrections in order to make a document more clear and concise.
  •  Initiate document Change Request approvals.
  •  Manage the project records during development.
  •  Use structured writing and content management expertise to re-work Instruction for Use documents resulting in more streamlined content.

Qualifications for success

  •  10+ years of experience working as a technical writer within the technology field
  •  5+ years of that experience creating medical device instructions for use
  •  Bachelor’s degree
  •  Experience using InDesign to create medical device labeling deliverables
  •  5+ years leading and mentoring technical writing teams
  •  5+ years managing technical communication project schedules
  •  Expert knowledge of the Technical Communications landscape, including demonstrated expertise in structured writing, style guides, and content editing
  •  Demonstrated experience working under the guidance of standard operating procedures governing the development of medical device products

Preferred qualifications

  •  Bachelor degree in Scientific and Technical Communications, or technical writing certification
  •  Proficient knowledge of Microsoft Project
  •  PMP certification
  •  Demonstrated knowledge of the code of federal regulations governing medical device labeling
  •  Experience working with content management systems as related to the modular reuse of content
  •  Knowledge of DITA
  •  Experience working with medical device labeling translations, including authoring content for translatability

A commitment to quality

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
  •  Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  •  Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  •  Demonstrated knowledge of the global regulations governing medical device labeling. This includes expert knowledge of 21CFR 820, 21CFR 801, EU MDR, all applicable EEC directives, etc

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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