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Engineering - Technical Writer

Fridley, MN 55432

Posted: 10/03/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614420 Is job remote?: No Country: United States

Job Description

  1. Can you please confirm your top 3 skills sets required?
    1. Technical writing / documentation skills
    2. Time management skills – self-directed
    3. Communication skills – comfortable interacting with engineers, scientists, and business leaders
  2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
    1. Writing/updating IFU/manual content to address quality related issues (corrections, clarifications, etc.)
    2. Conducting cross-functional reviews of labeling changes
    3. Documenting labeling development activities per process
  3. What products (if any) will this role support?  Neuromodulation and Pelvic Health portfolio
  1. What is your target years of experience?  Sweet spot is probably 2-5 years, but open to strong candidates with less/more experience.
  1. When do you plan to start interviewing?  Mid-September
  1. Will you be looking to hire and start ASAP or will the start date be delayed?  October start


As a Technical Writer, you will support the production of customer facing product documentation, including but not limited to: user guides, service manuals, and instructions for use (IFUs). This includes both clinician and patient labeling that accompanies medical device products within the Neuroscience portfolio. You may work on R&D projects such as new product development and released products maintenance (e.g., sustaining activities and legacy document updates), as well as quality- and compliance- driven projects to ensure our labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g., FDA, EU MDR, ISO, etc.). You will be responsible for both the content in the labeling as well as the supporting documentation, which may include design plans, design input requirements and tracing documents, review documentation, and verification reports. You may also be responsible for investigation, documentation, and resolution of labeling-related quality issues.

Typical responsibilities may include:
  • Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating CO/CA release.
  • Revise, edit, and format legacy product documentation as required, including but not limited to user’s guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs).
  • Ensure compliance of labeling with all applicable regulatory/QSR requirements.
  • Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation).
  • Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables.
  • Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
  • Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.
  • Continually review the document development process to ensure quality in labeling output.

Nice to Have:
  • Experience working in a federally regulated environment (FDA)
  • Experience with the European Union Medical Device Regulation (EUMDR)
  • Familiarity with Quality/CAPA processes and principals
  • Self-directed and highly organized
  • Ability to manage multiple priorities
  • Excellent communication skills
  • Advanced writing/editing skills
  • Cross-functional collaborative nature
  • Product Lifecycle Management software experience
  • Medical terminology experience
  • Familiar with the principals of neuromodulation
  • Product development workflow

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Fridley, MN

Unlock your potential in the vibrant community surrounding Fridley, Minnesota! Nestled in the Land of 10,000 Lakes, this region offers a perfect blend of urban amenities and natural beauty. With a plethora of job opportunities in fields like healthcare, manufacturing, and technology, Fridley is a hub for career growth. Imagine evenings spent at the beautiful Springbrook Nature Center, or catching a show at the historic Banfill-Locke Center for the Arts. Don't miss out on the chance to explore the Mississippi River by taking a stroll along the Riverfront Regional Park. Join our team and discover why Fridley is the ideal place to take your career to new heights!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.