FUJIFILM

  • Regulatory Affairs Specialist

    Job Locations US-MA-Lexington
    Posted Date 3 months ago(8/17/2018 11:12 AM)
    Requisition ID
    2018-2943
    Category
    Regulatory/Compliance
    Company (Portal Searching)
    FUJIFILM Medical Systems
  • Overview

    FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions to meet the needs of healthcare facilities today and well into the future. From an unrivaled selection of digital x-ray systems, to the Synapse® brand of PACS, 3D, VNA, RIS and CV (cardiovascular products), to advanced women’s health imaging systems, Fujifilm has products that are ideal for any size imaging environment. FUJIFILM Medical Systems U.S.A., Inc. also supplies high quality, technologically advanced endoscopes to the medical market. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, Connecticut with offices in New Jersey, North Carolina, Wisconsin and Florida. For more information please visit  www.fujifilmusa.com.

     

    External US

    Regulatory Affairs Specialist

     

    Job Summary

     

    This position is intended to provide Regulatory Affairs support to FUJIFILM Medical Systems U.S.A., Inc.  This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.

     

    Role and Primary Responsibilities

     

    • Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan
    • Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device
    • Prepare European Union Technical Files and International Regulatory Submissions
    • Coordinate Import/Export/Customs activities
    • Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records
    • Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records
    • Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action and maintain all records
    • Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action
    • Perform Corrective and Preventive Action activities
    • Perform Internal Audits and External Supplier Audits
    • Coordinate U.S. FDA remediation activities
    • Prepare Management Review Meeting presentations
    • Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards
    • Attend all department and company-wide team meetings as needed
    • Other duties as assigned 

    Minimum Requirements:

    • Bachelor Degree highly preferred
    • Three (3) or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
    • Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations
    • Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations)
    • Excellent leadership, communication, collaboration, team work and interpersonal skills
    • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
    • Excellent computer and internet search skills
    • Strong ability to multi-task and to meet business deadlines
    • Excellent organizational skills with an ability to think proactively and prioritize work

     

    This position description contains the general duties considered necessary to outline the principal functions of the job and shall not be construed as inclusive of all work requirements which may be inherent to successful performance. 

     

    The Company is an equal opportunity employer and does not discriminate, nor allow any employee, customer, contractor, vendor or visitor to discriminate, against any employee or applicant for employment on the basis of race, color, creed religion, sex (including pregnancy), gender, national origin, ancestry, ethnicity, age, genetic information, marital status, disability, sexual orientation, military status (including disabled veterans, recently separated veterans, other protected veterans and Armed Forces service medal veterans), protected activity (such as opposition to prohibited discrimination or participation in proceedings covered by anti-discrimination statutes) or any other characteristic protected by applicable federal, state or local law.

     

    FUJIFILM Medical Systems USA, Inc. offers a fantastic compensation package, including benefits, and a 401k program.  Visit us today to learn more about our exciting technologies and how you can make a difference.  To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page http://www.fujifilmusa.com/about/corporate_profile/fujifilm_companies/medical_systems/careers/#CB

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