C. R. Bard, Inc.

  • Regulatory Affairs Specialist

    Posted Date 4 weeks ago(4/26/2018 4:21 PM)
    Industry / Category
    Regulatory Affairs Specialist
    Job ID
    2018-11499
    Career Level
    experienced
    Division
    New Hope, MN / Lutonix
    Relocation
    Relocation Not Available
    Location
    US-MN-New Hope
  • Summary of Position with General Responsibilities

    This individual in this position will be responsible for global adverse event reporting, world-wide regulatory submissions and ensuring compliance with all the required regulations for assigned projects.

    Essential Job Functions

    Responsibilities:

    1. Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document and implement regulatory submission plans around product development/line extension goals.
    2. Prepares U.S. FDA submissions (e.g., IDE, PMA) as required and per applicable SOPs.
    3. Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.
    4. Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and International regulations and standards.
    5. Ensures adequate documentation of Bard Lutonix compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required.
    6. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Lutonix notified body.

    Basic Qualifications

    Qualifications:

    • Minimum of 2 years Regulatory Affairs medical industry or related industry experience (medical device, pharmaceutical and/or healthcare)
    • Experience with regulatory oversight and filing of reportable pre- and post-market adverse events and vigilance reports a plus
    • Bachelors of Science or technical degree  preferred
    • Excellent written and oral communication and technical writing skills  
    • Strong organizational and interpersonal skills
    • Ability to effectively manage multiple projects with shifting priorities
    • General knowledge of FDA and European medical device regulations, including IDE, PMA, & MDD
    • Able to apply independent decision making and analytical thinking skills
    • Proficiency with PC computer and Microsoft Office software
    • Technical knowledge of interventional vascular devices, related medical procedures and associated medical terminology preferred
    • Ability to work independently with minimal supervision

    Physical Demands

    While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

    Work Environment

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

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