C. R. Bard, Inc.

  • Regulatory Affairs Associate

    Posted Date 3 months ago(9/11/2018 1:17 PM)
    Industry / Category
    Medical Device/Regulatory Affairs
    Job ID
    Career Level
    entry level
    Bard Peripheral Vascular
  • 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#LI-SF1

    Summary of Position with General Responsibilities

    The position of Regulatory Affairs Associate is responsible for the development and support of product registrations in Japan through collaboration with International Business Unit contacts.  This is a 3 year project.  The candidate will be expected to write submissions in conjunction with other departments, requiring a working knowledge of the products and relevant regulations and guidance documents in Japan.

    Essential Job Functions

    • Prepares and supports product registrations in Japan in both newly introducing and sustaining products in the market as required and per applicable standard operational procedures (SOPs).
    • Provides general support for international regulatory team and projects, as needed.
    • Participates in product development and line extension teams, as required, to ensure that the product is in compliance with all international regulatory requirements. Develops documents and implements a regulatory submission plan around product development and line extension goals.
    • Assists in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements.
    • Provides international regulatory support on Engineering Change Orders, Design Change Notices, and other deviations.
    • Researches and responds to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).
    • Performs on special projects as required. 

    Basic Qualifications

    • Good written and oral communication skills in English language.
    • Basic computer skills (Windows environment).
    • Detail-oriented and critical thinking.
    • Ability to plan and schedule multiple priorities in a concurrent fashion.
    • Ability to review, collate and summarize scientific and technical data.
    • Good problem solving and analytical skills.
    • Intercultural communication skills desirable.

    Education and/or Experience

    • This position requires a Bachelors Degree in Law, Engineering, Biology or one of the Life Sciences.
    • The candidate 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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