C. R. Bard, Inc.

  • Clinical Risk Specialist - RN

    Posted Date 1 month ago(7/17/2018 3:20 PM)
    Industry / Category
    Clinical Risk Specialist/Healthcare
    Job ID
    2018-11829
    Career Level
    experienced
    Division
    Bard Medical
    Relocation
    No
    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 Clinical Risk Specialist - RN located in Covington, GA.

    Summary of Position with General Responsibilities

    The Clinical Risk Specialist will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries.  This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures

    Essential Job Functions

    • Determine whether a product malfunction or serious injury report needs to be filed with the FDA. Determine whether a 30 Day or 5 Day MDR report is required. Write and/or approve MDRs submitted.
    • FDA-MDR contact for responding to FDA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
    • MHRA-MDR contact for responding to MHRA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD. Approve decision trees for vigilance reports/international competent authority.
    • Review and approve all adverse events decision trees in Trackwise (Domestic and International). Approve vigilance/international competent authority report to authorities.
    • Generate weekly MDR and Supplemental Reports.
    • Assess clinical risk of reported complaints using risk management tools (DFMEA), medical literature, or consultations with medical professionals.
    • May perform complaint and quality investigations related to manufacturing, design or clinical use issues. Review and approve investigations performed by the manufacturing site or OEM Supplier.  Ensure consistency and attention to detail in performing and documenting complaint investigations.
    • Assist with Health Hazard Evaluations as needed for SPA and R002s
    • Analyze complaints and adverse events and communicate issues and resolutions to management.
    • Receive complaints and follow-up to collect relevant information from the user.
    • Make clinical severity and risk assessments, classify and assign FDA defect code. Where appropriate, arrange for HHE by a medical professional.
    • Monitor user related complaint trends. Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
    • Other duties as assigned.

    Basic Qualifications

    • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
    • Understands Fundamentals of Engineering Principles.
    • Ability to effectively manage time.
    • Ability to handle multiple task assignments.
    • Ability to translate quality requirements into product specifications.
    • Ability to interpret Regulations, Corporate, Division and Department Procedures.
    • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.  Ability to interface with regulatory bodies to present technical information.
    • Comprehensive knowledge of quality systems and relationship to business.

     

    Education and/or Experience

    • Bachelor’s degree required. Nursing degree combined with two years of clinical experience preferred.
    • Two years nursing/clinical experience
    • Preferred four (Level I) years of experience with FDA regulated industry including three years in complaint handling, MDR/adverse event reporting, and performing complaint investigations preferred.
    • Experience with complaint handling software (Trackwise or equivalent), Access Databases, and Excel (Pivot Tables and Charts).

    Physical Demands

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel.  The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to fifteen pounds. Employee is required to meet with other personnel in other areas of the building.  Specific vision abilities required by this job include close vision.

    Work Environment

    This position works in a normal office environment.  The noise level in the work environment is quiet to moderate.  This position also has exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards.  Must be trained in blood-borne pathogens and handling bio-hazards materials.

     

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