Senior Technical Writer

Karen Borresen

Burnsville, MN
Posted 4 weeks ago

Imricor is the first and only company in the world to bring commercially viable and safe iCMR products to the catheter ablation market.  As we continue to commercialize Imricor is growing and looking for employees who want to help bring this therapy to patients all over the world. We value all applicants and encourage diverse candidates to apply.

Basic Function

This technical writer position develops and edits technical documentation, including product labeling, instructions for use, and guides to support regulatory submissions. This position works closely with development, regulatory, quality and marketing to develop product documentation in compliance with medical device regulations and standards. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

  • Responsible for authoring and maintaining technical documentation including product labels, product manuals, instructions for use, process flows and work instructions.
  • Collaborate with development, regulatory, quality, operations and marketing to develop/revise the technical documentation.
  • Manage the translation of product labeling, as needed.
  • Work with operations and quality to qualify and maintain approval for labeling suppliers (e.g., printing suppliers, translation suppliers)
  • Comply with applicable FDA and International regulatory laws/standards
  • Other duties as assigned or required.

Minimum Qualifications

  • Bachelor degree in English, Technical Writing, Communication, or related discipline or equivalent education/ training.
  • 5+ years’ technical writing experience in the medical device industry.
  • Demonstrated knowledge of FDA, EU and industry standard labeling requirements
  • Strong communication skills, both verbal and written.
  • Must be able to work independently under limited supervision.

Preferred Qualifications

  • Experience using Adobe InDesign or similar application
  • Experience working with 510(k) and/or IDE and/or PMA devices and/or submissions
  • Quality Systems knowledge
  • Demonstrated ability to effectively manage multiple projects and priorities.
  • Skills in multiple computer-based tools and software such as Illustrator, Word, PowerPoint, Excel, and Adobe Acrobat.

Working Conditions

  • Light work, exerting up to 20 lbs. of force or less.
  • Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
  • Requires interaction with a computer and communication with peers and co-workers.
  • Hybrid work module available

To apply, please submit your resume and cover letter documents below.

Imricor is an equal opportunity employer and encourages diverse candidates to apply.

Job Features

Job CategoryQuality
Position reports to:VP of Regulatory, Quality
Position Status:Exempt

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