C. R. Bard, Inc.

  • Regulatory Affairs Associate

    Posted Date 1 month ago(10/12/2018 1:08 PM)
    Industry / Category
    Regulatory Affairs Associate/Healthcare
    Job ID
    2018-11792
    Career Level
    experienced
    Division
    Bard Medical Division
    Relocation
    No
    Location
    US-GA-Covington
  • Overview

    BD Urology and Critical Care is currently hiring Regulatory Affairs Associate.  This position is a growth opportunity based in Covington, GA.  Formerly Bard Medical, we have joined Becton-Dickinson a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. 

     

    Summary of Position with General Responsibilities

    This position is responsible for management of regulatory databases, provides product technical expertise, as well as assisting RA management in regulatory activities, including assessments, strategies and technical file maintenance.

    Essential Job Functions

    • Manage regulatory databases (UDI, products, technical files, etc.)
    • Research technical requirements for regulatory databases
    • Assist in technical interface between regulatory specialist and labeling specialist
    • Provide guidance on UDI labeling requirements as subject matter expert
    • Manage the technical file organizers in Master Control per guidelines
    • Assist in preparation of regulatory submissions (510(k)s, technical files, design dossiers)

    Basic Qualifications

    • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
    • Strong interpersonal skills in the areas of written and verbal communication
    • Must be able to prioritize and handle multiple projects concurrently
    • Must be self-motivated, work independently and have the ability to work with minimal supervision
    • Must be computer literate, proficient in Master Control, desired
    • Must be able to meet goals on time
    • Must have be able to research technical topics (product materials and attributes)

    Additional Desirable Qualifications Skills and Knowledge

    • Must be computer literate, proficient in Master Control, desired
    • Must be a team player
    • Must live 50 miles in distance from facilty in Covington GA

    Education and/or Experience

    • BS/BA preferred
    • Five years’ experience in medical device/FDA regulated industry
    • Regulatory Affairs Certification (RAC) desired

    Physical Demands

    • While performing the duties of this job, the employee is regularly required to sit, talk, and hear.  The employee may occasionally lift objects up t 25lbs.

    Work Environment

    Traditional office environment.   #LI-CW1

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