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    Senior Director/Director of Regulatory Affairs - Chicago, IL, United States - Tempus

    Tempus
    Tempus Chicago, IL, United States

    Found in: Lensa US 4 C2 - 1 day ago

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    Description

    Passionate about precision medicine and advancing the healthcare industry?

    Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

    At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Director/Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.

    Responsibilities

    • Developing and leading global regulatory strategies to support business objectives
    • Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc.
    • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale
    • Developing and executing premarket and postmarket regulatory project plans and strategies
    • Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications
    • Work closely with business leadership to ensure regulatory strategy aligns with commercial goals
    • Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently

    What your background might look like

    • Experience with complex medical devices, such as some combination of:
      • Software and artificial intelligence based devices
      • Clinical decision support software
      • Medical imaging
      • Oncology
      • Cardiology
    • Experience with:
      • Premarket Approval (PMA) applications, de novo requests for reclassification, 510(k)s, investigational device exemption (IDE) requirements
      • Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR
      • Software validation and risk management
      • Cybersecurity in medical devices
      • Machine learning validation requirements
      • Changes to medical devices that trigger reporting or regulatory submissions
      • Relevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards
    • Strong communication, presentation and interpersonal skills
      • Experience leading cross-functional teams of subject matter experts
      • Experience working in a startup-like environment
      • Experience interacting with regulators
      • Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas
      • Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs
      • Excellent attention to detail
      • Strong project management skills and the ability to execute on project plans in a fast-paced environment
    • Scientific background
      • Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred.
      • Minimum of 10+ years of experience in Regulatory Affairs experience related to medical devices
      • Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

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