C. R. Bard, Inc.

  • Regulatory Affairs Specialist

    Posted Date 1 month ago(4/24/2018 12:38 PM)
    Industry / Category
    Medical Device/ Regulatory Affairs
    Job ID
    2018-11485
    Career Level
    experienced
    Division
    Bard Peripheral Vascular
    Relocation
    TBD
    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. #LI-JC1

    Summary of Position with General Responsibilities

    The position of Regulatory Affairs Specialist is responsibe for the development and support of China FDA product registrations with International Business Center (IBC) contacts in China.  The candidate will be expected to write submissions in conjunction with other departments, requiring a working knowledge of the products and relevant Chinese regulations and guidance documents.

    Essential Job Functions

    1. Prepares and supports China FDA first time, renewal, and change registration submissions as required and per applicable SOPs.
    2. Provides general support for international regulatory team and projects, as needed.
    3. 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.
    1. Provides international regulatory support on Engineering Change Orders, Design Change Notices, and other deviations.
    2. Knowledgable of Bard Peripheral Vascular’s compliance to FDA, European and international regulations and standards.
    3. Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).
    4. Special projects, as needed.

    Basic Qualifications

    1. Knowledge of U.S., European, and international regulations and standards.
    2. Minimum of 2 years of regulatory experience, preferably within the medical device industry.
    3. Experience working with international businesses or cultures.  

    Additional Desirable Qualifications Skills and Knowledge

      1. Excellent communication (both verbal and written) skills.
      2. Sufficient computer skills (Windows environment).
      3. Good problem-solving and analytical skills. 
      4.  Detail oriented with strong Excel knowledge. Ease with manipulation of data.
      5. Mandarin language skills preferred.
      6. Knowledge of Chinese regulations and standards preferred.

     

     

     

    Education and/or Experience

    1. Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.
    2. Minimum of 2 years of RA related experience. 

    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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