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Endologix, Inc Regulatory Affairs Specialist - International in Irvine, California

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 in Asia Pacific and Latin America.

  • Ensure applicable international regulations related are met

  • Prepare high quality international submissions to established timelines

  • Coordinate with international contacts on all regulatory activity (i.e. change assessments, submissions, etc.)

  • Develop and implement regulatory strategies

  • Update departmental procedures, as required

  • Support and work with cross functional departments

  • Maintain up-to-date knowledge on international regulatory requirements

  • Perform other duties as assigned by supervisor

  • Knowledge of global medical device regulations

  • Experience preparing regulatory submissions

  • Ability to interpret regulatory standards and guidance

  • Ability to work in a fast-paced, technically challenging environment

  • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities

  • Effective interpersonal skills and problem solving techniques

  • Experience in negotiating to achieve goals and meet timelines

  • Excellent applied thinking and technical writing skills

  • Strong oral and written communication and organization skills required

  • Product development team experience (preferred)

  • Experience with cardiovascular devices (preferred)

Education:

  • Bachelor’s degree in a scientific discipline or equivalent

Experience:

  • Minimum of 2 years in Regulatory Affairs.

ID: 2020-2322

External Company Name: Endologix

External Company URL: http://www.endologix.com/

Street: 2 Musick

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