What are the responsibilities and job description for the Director / Senior Director, Regulatory Affairs position at Tempus?
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 the 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.
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
- Working 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
- Managing and transitioning Quality Assurance responsibilities, e.g., internal and external audits, documentation of compliance with Quality and Regulatory requirements and Quality Management System
What your background might look like
Software and artificial intelligence-based devices
Premarket Approval (PMA) applications, de novo requests for reclassification, 510(k)s, investigational device exemption (IDE) requirements
Experience leading cross-functional teams of subject matter experts
Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred.
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