C. R. Bard, Inc.

  • Regulatory Affairs Assistant

    Posted Date 2 weeks ago(10/3/2018 8:56 PM)
    Job ID
    2018-12409
    Career Level
    entry level
    Relocation
    No
    Location
    US-MN-New Hope
  • Overview

     

    Trailblazing Innovation for Patients

    BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

    Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products.  Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients.  Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.

     

    Summary of Position with General Responsibilities

    This position will be responsible for providing regulatory support to the international and internal regulatory team for submission filings and maintenance of regulatory database systems for compliance with required regulations.

    Essential Job Functions

    • Provide regulatory documentation to international regulatory team for preparation of the local submission filings.
    • Plan, organize and maintain international filing status and communication status to product development project teams.
    • Drive documentation reviews required to support international filings.
    • Ensure international regulatory affairs files are updated and maintained as required.
    • Develop working relationships with international regulatory team and gain understanding of the international support document necessary for each associated countries.

    Basic Qualifications

    • GED or High School Diploma required, Bachelors Degree preferred
    • 4 years’ experience working in office environment or equivalent.
    • Excellent written and oral communication skills
    • Strong organizational and interpersonal skills
    •  Ability to effectively manage multiple projects with shifting priorities
    • Independent decision making and analytical thinking skills
    • Proficiency with Microsoft Office software
    • Ability to work independently with minimal supervision

     

     

    #LI-OPS

    Physical Demands

    While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties. Employee must be able to wear personal protective equipment. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

    Work Environment

    While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fastpaced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the
    workforce.

     

    This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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