• Labeling Supervisor/Project Manager (RA Supervisor)

    Location US-CA-Hercules
    Requisition ID
    2018-8944
    # of Openings
    1
    Category
    Quality & Regulatory
  • Overview

    The primary responsibilities include the project management and leadership of the NorCal labeling processes and team by supporting the strategic planning and supervision of resources, liaison with stakeholders, and project management for the product labeling operations for new products and required modifications to products.

    Responsibilities

    • Supervision of NorCal labeling process Technical Writers and Desktop Publishers.
    • Plays a critical role in project management excellence of the label design and supply chain processes including oversight of required changes and implementation processes through coordinating cross functional and multi-site interactions and driving timelines to meet business needs with stakeholders from Planning, Procurement, Manufacturing, Regulatory, Quality, and Marketing.
    • Accountability to deliver complete labeling projects on time, on budget, and in accordance with established procedures and within the specifications.
    • Develop metrics and reports on labeling project progress to stakeholders, including management.
    • Additional responsibilities include support for regional China labeling projects, UDI implementation, and other coordination of other regulatory projects.

    Qualifications

    • Bachelor’s degree in technology or related field is required. 
    • 2+ years’ relevant regulatory and project management experience in an FDA regulated environment that includes supervisory experience or equivalent combination of education and experience.
    • Project management training is required with professional certification (e.g., PMP) preferred.
    • Proficiency in SAP and/or other ERP Systems is required.
    • Proficiency in Desktop Publishing and Adobe InDesign is recommended.
    • Knowledge of change control and product labeling requirements in the medical device industry is required.
    • Ability to translate labeling strategy into action to meet timelines.
    • Leadership and influencing skills to be effective in a matrixed organization with geographically dispersed teams.
    • Strong Stakeholder/Customer Orientation and Focus.
    • Effective Communication Skills (Written and Verbal).

     

     

    About Bio-Rad:

     

    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

     

    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

     

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    Agency Non-Solicitation:

     

    Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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