• Regulatory Affairs / Quality Systems Sr. Specialist

    Job Locations US-CA-Irvine
    Job ID
    7564
    Experience (Years)
    5
    Category
    Healthcare/Medical
  • Company Overview

    About Canon U.S.A., Inc.
    Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2017† and is one of Fortune Magazine's World's Most Admired Companies in 2018. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com.
    † Based on weekly patent counts issued by United States Patent and Trademark Office.
    All referenced product names, and other marks, are trademarks of their respective owners.
    We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.

    Position Overview

    We have an exciting opportunity in our Irvine office to assist Department management in the Healthcare Solutions Division with quality programs and system activities in the medical device arena.  The ideal candidate will ensure the Company adheres to FDA quality and regulatory guidelines.
     
     
    #LI-NF1 #CUSA

    Responsibilities

    - Oversee product complaint processing and MDR program including trending, reports and presentations. Administers Corrective Action and Preventative Action (CAPA)
    - Manage all activities of Document Control process.
    - Perform internal and external auditing of systems, departments, products, as required. Issue audit reports and ensure timely audit closures.
    - Coordinate international registrations projects with Department Management, including procuring documents and legalizations from regulatory, County, State and specific country legal bodies. Interface with Sales Administration on vendor compliance issues.
    - Support the maintenance of HealthCare Solutions quality systems to ensure compliance with QSR, ISO, and Corporate requirements.
    - Perform incoming, in-process, and integration inspection activities. Issue documentation, as applicable.
    - Support regulatory inspections, as applicable.
    - Author and revise Department SOP’s, Department Procedures, policies and forms.

    Qualifications

    - Bachelor’s Degree required, preferably in science or healthcare discipline.
    - Minimum five years in Regulatory Affairs and/or Quality Systems (medical device experience highly preferred)
    - Demonstrated familiarity with FDA QSR, and specific ISO standards.
    - Excellent written and verbal communication skills
    - Strong computer skills, i.e. Word, Excel, Power Point, etc.
    - Results oriented, self-starter and dependable.
    - Ability to lift up to 20 lbs
     If you are not reviewing this job posting on our Careers’ site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers

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