• Director of Regulatory Affairs

    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

    • Guide team members in the compilation, creation and completion of regulatory submissions
    • Participate in and/or facilitate internal and external audits
    • Review, monitor and approve programs and documentation, as assigned, to ensure compliance with relevant standards, regulations and guidance documents
    • Coordinate, liaise and participate with internal teams to provide guidance on regulatory and/or quality systems compliance
    • Learn and understand changes to the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents in order to monitor and ensure conformance
    • Manage and participate in projects to maintain and improve Applied Medical’s Quality System in accordance with national and international standards and regulations
    • Lead teams to identify and implement systems to improve the overall efficiency within the Regulatory Affairs and Quality Systems (RA/QS) teams
    • Provide guidance in quality data trending and analysis and evaluate and present analysis reports
    • Define the regulatory strategy of new development projects and product changes
    • Train and mentor new team members and complete performance reviews
    • Perform additional duties and responsibilities as required by leadership
    • Provide training on RA/QS requirements to all team members

    Position Requirements

    • Ability to work independently and as part of a team
    • Analytical, meticulous and detail oriented
    • Assertive and not afraid to ask questions
    • Effective oral and written communication/presentation skills
    • Friendly disposition, positive attitude and customer service oriented
    • Able to multi-task, organize and prioritize
    • Ability to interpret existing and emerging regulations, standards, or guidance documents and understand the potential impact on the organization
    • Strong technical writing skills
    • Ability to provide technical input related to regulatory and quality systems
    • Ability to analyze, using statistical techniques, and present data regarding products, projects and the Quality Management System
    • Effective leadership, mentoring and guidance skills
    • Bachelor’s degree in engineering, physical or biological sciences, or other technical discipline
    • Training in quality systems including QSR/GMS's, ISQ/CE marking
    • 5+ years of experience in engineering and/or RA/QS in the medical device industry, or equivalent experience

    Preferred

    • Quality principals

    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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right position?

    We can recommend positions specifically for you! Click here to get started.