Senior Director/Director of Regulatory Affairs

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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