Endologix, Inc

  • Sr. Regulatory Affairs Specialist - International

    Job ID
    2018-1876
    Location
    US-CA-Irvine
    Category
    Regulatory
  • Overview

    This position is responsible for the preparation and maintenance of international regulatory filings to meet corporate objectives, and for the timely completion of other assigned activities related to regulatory support activities worldwide.

    Responsibilities

    • Prepare high quality international filings/registrations to established timelines.
    • Represent RA department in assigned project meetings and provide regulatory guidance as appropriate.
    • Coordinate with international contacts on product changes and regulatory notification / approval requirements.
    • Prepare reports to meet international regulations and reporting requirements.
    • Review and approve document change orders and prepare letters-to-file.
    • Update departmental procedures, as required.
    • Ensure applicable international regulations are met.
    • Maintain up-to-date knowledge on international regulatory requirements.
    • Other duties as assigned by supervisor.

    Qualifications

    • Extensive knowledge of global medical device regulations.
    • Comprehensive knowledge of quality systems and relationship to business.
    • Ability to facilitate and provide leadership when interpreting regulatory standards and guidances.
    • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
    • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
    • Effective interpersonal skills/diplomacy and problem solving techniques.
    • Excellent applied thinking and technical writing skills.
    • Strong communication and organization skills required.
    • Product development team experience.
    • Experience in writing global regulatory strategies.

    Education:

    • Minimum bachelor’s degree in a scientific discipline or equivalent.

    Experience:

    • Minimum of 6 years relevant experience.

     

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