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Regulatory Affairs Specialist Senior

Company: Roche
Location: Tucson
Posted on: June 16, 2019

Job Description:

As a Regulatory Affairs Specialist, Senior, you will support submissions in the US and ex-US. In addition, you will participate on project teams with internal and external partners. Aid in the management and completion of annual reporting of product and process changes, clinical trial applications, and other periodic requirements.

Responsibilities


  • Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with global directives and regulations.
  • Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
  • Interface with regulatory authorities on regulatory and technical matters, as directed.
  • May provide regulatory support on project teams.
  • Assist in the creation of Operating Procedures and policy guidelines.
  • Assist in review of labeling changes, advertising and promotional activities, etc.
  • May assist as the internal regulatory consultant for on-market product issues.
  • Assist in review of proposed device changes.
  • May perform other duties as required or assigned.

    Qualifications

    • B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred. Regulatory Affairs Certification preferred.
    • 3 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred.
    • Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred.
    • Experience working in a cross-functional team setting is preferred.

      Roche is an equal opportunity employer.Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

Keywords: Roche, Tucson , Regulatory Affairs Specialist Senior, Other , Tucson, Arizona

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