Humera - Administrative and Professional Staffing

Technical Writer, Senior

Location
St Paul, MN, United States
Salary
Contact For Rate
Posted
Mar 11, 2018
Closes
Mar 13, 2018
Job Type
Employee
Employment Status
Full Time
Humera is hiring for a Senior Technical Writer at a medical technologies company in Minnetonka,MN. Our client is committed to innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease.

This is a long-term, contract assignment!
Duties:
  • Write and manage IFUs for CATD products
  • Gather input from Engineering, Marketing, Clinical, and Regulatory etc., to define specific requirements for IFUs by attending project meetings and meeting with individual experts as necessary
  • Enhance professional appearance and readability of product IFUs by editing them for grammar, consistency, style, and format
  • Coordinate final IFU implementation to ensure that all requirements and deadlines are met (including translation, freelance graphic designer, documentation release, and print vendors, etc.)
  • Produce IFU content by following defined requirements, using the following prescribed software FrameMaker, InDesign

Requirements:
  • Technical writing experience in a medical/pharma device industry
  • Prior experience writing IFUs for end-users (clinicians and/or patients)
  • Understanding of FDA and EU medical device labeling regulations
  • Knowledge of ISO, TuV and 21CFR Part11 regulations related to medical device labeling
  • Minimum 3 years experience

Schedule:
    8:00 am to 5:00 pm Monday through Friday

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