• Regulatory Affairs Analyst

    Position Location US-CA-Rancho Santa Margarita
  • _________________________________________________________________________________

    Applied-Medical-Logo-w-Tag_H_Teal_cropped

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid business growth and expansion. Applied Medical has been developing and manufacturing advanced surgical technologies for nearly 30 years, and has earned a strong reputation in healthcare.  Our dedication to delivering the highest quality products and unique business positioning, provides our team members with the unique ability to contribute in a larger capacity than is possible in typical positions.

    Position Description

    As a Regulatory Affairs Analyst you will be responsible for working within the framework of a team and performing the following activities:

    • Coordinate and support activities, with guidance and supervision, related to regulatory compliance in various countries
    • Stay up-to-date on changing standards and regulatory requirements
    • Provide analytical, operational and technical support to customers, regulatory agencies, suppliers, and internal teams
    • Support internal and external audit activities
    • Meet and exceed customer expectations
    • Understand and follow Applied Medical's Quality Systems per training
    • Perform additional duties and responsibilities as required by leadership

    Position Requirements

    This position requires the following skills and attributes:

    • Ability to work independently and as part of a team
    • Committed to continuous improvements in quality
    • Analytical, meticulous and detail oriented
    • Assertive and not afraid to ask questions
    • Effective oral and written communication/presentation skills
    • Friendly, good attitude and customer service oriented
    • Ability to multi-task, organize and prioritize
    • Knowledge of existing and emerging regulations, standards or guidance documents
    • Bachelor’s degree in engineering, physical or biological sciences, other technical discipline or equivalent experience is preferred

    Benefits

    • Training and mentorship with ongoing learning and development courses
    • On-campus wellness activities
    • Comprehensive medical and dental coverage
    • Education reimbursement program
    • 401(k) program with employer match
    • Generous vacation accrual and paid holiday schedule

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