C. R. Bard, Inc.

  • Regulatory Affairs Associate

    Posted Date 1 week ago(7/12/2018 11:43 PM)
    Industry / Category
    Medical Device/Regulatory Affairs
    Job ID
    2018-11764
    Career Level
    entry level
    Division
    Bard Peripheral Vascular
    Relocation
    No
    Location
    US-AZ-Tempe
  • Overview

    Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare.  BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.

     

    We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.

     

    Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.

    Summary of Position with General Responsibilities

    • This position implements BDPI domestic and international regulatory affairs procedures. This position may also act as a liaison to Corporate Law Department, providing requested information.

    Essential Job Functions

    1. Supports senior Regulatory personnel prepare new product marketing submission for the FDA (510k, PMA).
    2. Maintains all Regulatory Affairs documentation.
    3. Assists as a Regulatory representative on New Product Development teams.
    4. Supports all international Regulatory requests.
    5. Sends out notifications of change to the Notified Body as required.
    6. Supports divisional and corporate litigation requests as needed.
    7. Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements.
    8. Performs on special projects as required. 

    Basic Qualifications

    Ability to plan and schedule multiple priorities in a concurrent fashion.

    Ability to review, collate and summarize scientific and technical data.

    Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.

    Excellent problem solving and analytical skills.

    Good written and oral communication skills.

    Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy.

    Complete work with minimal supervision and ability to work independently.

    Knowledge of federal medical device regulations. 

    This position also requires good writing and strong organizational skills.

    Education and/or Experience

      1. This position requires a Bachelors Degree in Law, Engineering, Biology or one of the Life Sciences.
      2. The incumbent may have 0-1 year experience in a regulatory or documentation environment or related field   

      

    Physical Demands

    While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

    Work Environment

    While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

     

     

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