Irvine, California

IFU Writer/Coordinator

Kelly Services is currently seeking a IFU Writer for a long-term engagement with one of our Global Pharmaceutical clients in Irvine, CA. This opportunity can be home based with ability to come into the office few days a week in Irvine. 

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

SUMMARY

Under limited supervision, the IFU Writer/Coordinator gathers, composes, and edits technical, medical and safety information into clear, concise, readable documents for both a medical and non-medical audience.  The IFU Writer/Coordinator is responsible for writing User Manuals, Instructions for Use, and other related documents.

 

RESPONSIBILITIES

  • Work with project team members, including R&D and operations engineering, quality engineering, regulatory, marketing, technical services, and others to produce User Manuals, Instructions for Use, and other related documents.
  • Manage multiple documentation projects in various stages of production to ensure critical deadlines are met.
  • Organize, develop, write, and edit to compose clear, concise, and readable documents that may include diagrams, flow charts, photos, and graphics that must be captured and manipulated to support content.
  • Maintain and promote adherence to company documentation style guides and content specifications.
  • Ensure documentation adheres to acceptable writing standards for grammar, punctuation, and sentence form and structure.
  • Manage translation of documentation.
  • Facilitate meetings with SMEs or project teams to review documents.
  • Ensure compliance with labeling requirements for medical devices
  • Follow all company guidelines related to health, safety, and environmental practices.
  • Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
  • Perform other duties assigned as needed.

 

EDUCATION and/or EXPERIENCE:

  • 10+ years of relevant experience or equivalent combination of education and work experience. 
  • Experience in the medical device field required.
  • Proficient in Microsoft Word and Excel.
  • Familiar with PowerPoint, Visio, and graphic and photo management software.
  • Familiar with document management systems.
  • Familiar with design documents for products that include hardware and software.
  • Photography experience desirable.
  • Knowledge of regulatory requirements for medical device labeling desirable.

 

REQUIRED KNOWLEDGE & SKILLS:

  • Must be able to write documentation in a manner that customers with limited to highly proficient medical safety and relevant product knowledge can understand.
  • Must be able to manage and meet multiple project deliverables and deadlines.
  • Ability to work independently and have proven time management skills.
  • Good research, information gathering, and analytical skills.
  • Excellent English, spelling, and grammar skills.
  • Able to adapt to a fast-paced, changing environment
  • Able to analyze project scope, setting interim deadlines for documentation development.
  • Must be able to work well with all levels of subject matter experts, from entry level to management.
  • Must be well organized, thorough, and detailed oriented with an eye for aesthetics.
  • Must be able to review and edit content to ensure consistency and documentation standards are met.
  • Must display a willingness to make decisions, exhibit sound and accurate judgment, support and explain the reasoning for decisions, and include the appropriate people in the decision-making process.
  • Ability to learn regulatory requirements.
  • Must be able to work with a minimum of supervision.

 

 



You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Irvine, California

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