Endologix, Inc

  • Regulatory Affairs Specialist - International

    Job ID
    2018-1894
    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.

    Responsibilities

    • Prepare high quality international filings/registrations to established timelines
    • Coordinate with international contacts on all regulatory activity (i.e. Product changes and regulatory notification / approval requirements)
    • Develop and implement regulatory strategies
    • Update International departmental procedures, as required
    • Ensure applicable international regulations related are met
    • Support and work with cross functional departments
    • Maintain up-to-date knowledge on international regulatory requirements
    • Perform other duties as assigned by supervisor

    Qualifications

    • Extensive knowledge of global medical device regulations
    • Experience preparing international regulatory submissions (Asia Pacific, Latin America preferred)
    • Ability to interpret regulatory standards and guidance and to provide associated summaries to leadership
    • Ability to work in a fast-paced, technically challenging environment
    • Must be self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities
    • Effective interpersonal skills/diplomacy and problem solving techniques
    • Experience in negotiating to achieve goals
    • Excellent applied thinking and technical writing skills
    • Strong oral and written communication and organization skills required
    • Product development team experience (preferred)
    • Experience with implantable cardiovascular devices (preferred)

    Education:

    • Bachelor’s degree in a scientific discipline or equivalent

    Experience:

    • Minimum of 2 years in Regulatory Affairs

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