Technical Writer, Global Implant Systems

US, US, CA - San Diego

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: No travel required

Location: CA - San Diego

Ref#: 100630

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Job Description

NuVasive is seeking a Documentation Engineer (or Technical Writer) to join our Global Implant Systems (GIS) product development team. You will have the responsibility of creating and maintaining a wide array of supporting documentation including elements of Design History Files (Risk Analyses, Product Requirements Documents, Verification & Validation Reports, etc.), customer-facing documents (labeling, Instructions for Use, Supplemental Cleaning Instructions, etc.) and Regulatory submissions (product descriptions, worst case justifications, technical monographs, etc.).  


Essential Responsibilities

  • Follow an engineering document control process
  • Define, create, and maintain design control documentation in compliance with FDA regulations and internal procedures
  • Collaborate with subject matter experts to create documents that are clear, concise and audience-appropriate
  • Generate and edit Quality System documentation satisfying FDA QSRs, ISO 13485 and MDD requirements
  • Create and maintain elements of Design Control documentation and Design History Files
Basic Qualifications
    • Bachelor’s degree
    • 4+ years of relevant experience
    • Effective communication skills with strong confidence to present before groups of customers, vendors, peers, and leadership.
    • Proficiency with Microsoft Office with a strong ability to write business reports and correspondence as well as the ability to speak effectively before groups of customers, employees, and management of the organization
    Preferred Qualifications
    • Familiarity with EtQ or other Quality Management System
    • Experience with EU Medical Device Regulation (MDR) readiness.
    • Medical device experience, specifically spine.
    • Experience with copy editing

    NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.

    About NuVasive
    NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
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