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 Regulatory Affairs Specialist 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 and assisting with 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, including assessments of change controls
-
Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records
-
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
CHI: $90,000-$120,000
The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
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.
About Us
Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics.
We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives.
Why Work Here?
We’re looking for people who can change the world.
Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.
