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Director of Regulatory Affairs

Tempus

Tempus

Legal
Washington, DC, USA
Posted on Friday, October 27, 2023

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have 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 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. We are seeing industry expertise with medical devices, in vitro diagnostics, laboratory-developed tests, clinical decision support software and software as a medical device (SaMD).

Responsibilities

  • Developing and leading global regulatory strategies to support business objectives and companion diagnostic partnerships
  • Assisting with preparation of submissions, supplements, and correspondence with regulatory authorities, including FDA 510(k), Premarket Approval Application (PMA), De Novo authorizations, and Investigational Device Exemption (IDE) applications
  • Developing and executing premarket and postmarket regulatory project plans and strategies
  • Maintaining Tempus’ compliance with regulatory requirements for marketing medical devices in the United States and abroad
  • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale
  • Overseeing the creation and maintenance of claims and device labeling
  • Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and ensure that standard operating procedures produce all necessary regulatory output
  • Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently

What your background might look like

  • Experience with complex FDA regulated medical devices, such as some combination of
    • Companion diagnostics
    • Software and artificial intelligence based devices
    • Next generation sequencing
  • Experience with regulatory issues, such as:
    • 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
    • Analytical and clinical validity for diagnostics
    • Changes and modifications to medical devices that trigger reporting or regulatory submissions
    • Relevant sections of 21 CFR, ISO, 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
    • Experience conducting regulatory training
    • Ability to work well with quality, clinical, bioinformatics, and laboratory teams
    • 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 5+ 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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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.