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Regulatory Affairs Specialist Senior Full-time

at Roche in Arizona (Published at 09-02-2019)

    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.

  • Who we are
    Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.
    Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual?s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.


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