C. R. Bard, Inc.

  • Regulatory Affairs Specialist I

    Posted Date 1 month ago(11/16/2018 5:22 PM)
    Industry / Category
    Regulatory Affairs Specialist
    Job ID
    2018-11819
    Career Level
    experienced
    Division
    Bard Medical Division
    Relocation
    Yes
    Location
    US-GA-Covington
  • Overview

     

    Bard has joined BD, together advancing the world of health.  BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Regulatory Affairs Specialist I located in Covington, GA.

    Summary of Position with General Responsibilities

    The position of Regulatory Affairs Specialist is responsible for the development and support of China FDA product registrations with International Business Center (IBC) contacts in China. The candidate requires a working knowledge of the products and relevant Chinese regulations and guidance documents.

    Essential Job Functions

    • Prepares and supports China FDA first time, renewal, and change registration submissions as required and per applicable SOPs.
    • Provides general support for platform regulatory teams 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.
    • 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 special projects as needed.

    Basic Qualifications

    • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
    • Must have excellent written and verbal communication skills
    • Must be a team player
    • Must be able to prioritize and handle several projects concurrently
    • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities
    • Must be computer literate with strong Excel knowledge
    • Must be able to meet goals on time
    • Must have knowledge of U.S., European, and international medical device regulations and standards. Knowledge of Chinese regulations and standards preferred.
    • Must have experience working with international businesses or cultures

    Education and/or Experience

    • BS in a scientific discipline with 1-3 years employment in the areas of project registration, compliance or quality systems; or
    • Combination of education and experience determined to be equivalent
    • Regulatory Affairs Certification (RAC) desired
    • Fluent in Mandarin 

    Physical Demands

    • Must be able to operate computer and office equipment as needed
    • Must be able to travel via airlines as needed

    Work Environment

    Traditional office environment.   #LI-CW1

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