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Manager, Regulatory Affairs

Company: Roche
Location: Pleasanton
Posted on: June 15, 2019

Job Description:

The Manager Regulatory Affairs will direct and oversee all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc. Ensures timely preparation of organized and scientifically valid applications. Provides expertise in translating regulatory requirements into practical, workable plans.

Essential Functions:

  • Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products (including compliance).
  • Manages the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings.
  • Monitors and assesses Regulatory developments (e.g. Federal Register publication/notices, FDA guidelines) related to the Company's products.
  • Reviews product labeling to ensure conformance with Regulatory requirements and/or approved product claims.
  • May serve as a contact with affiliates to achieve international registration of devices.
  • Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
  • Position may have HR responsibility for direct and indirect reports which includes hiring/firing decisions, interviewing, selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.
  • Oversees the "agent in charge" for audits and serves as primary liaison with plant compliance officers to direct strategy and documentation requests during an audit.

    Minimum Qualifications:

    • Bachelor's degree or equivalent
    • Master's degree/PhD. or equivalent (preferred)
    • Typically, 8+ years regulatory affairs experience in the medical product industry.

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

Keywords: Roche, San Francisco , Manager, Regulatory Affairs, Executive , Pleasanton, California

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