Regulatory Affairs Specialist
$90K - $120K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Strong project management skills and the ability to execute on project plans in a fast-paced ...

$90K - $120K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Strong project management skills and the ability to execute on project plans in a fast-paced ...
$90K - $120K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Strong project management skills and the ability to execute on project plans in a fast-paced ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Soft Skills: Excellent written and verbal communication skills with strong project management ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Soft Skills: Excellent written and verbal communication skills with strong project management ...
Chicago, IL · On-site
$180K - $250K/yr
Bridge the gap between Data Science, Biostatistics, and Product teams to productize successful novel methods, ensuring they are scalable across the Tempus ecosystem. * Project Management & Quality:
Chicago, IL · On-site
$180K - $250K/yr
Bridge the gap between Data Science, Biostatistics, and Product teams to productize successful novel methods, ensuring they are scalable across the Tempus ecosystem. * Project Management & Quality:
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Soft Skills: Excellent written and verbal communication skills with strong project management ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Soft Skills: Excellent written and verbal communication skills with strong project management ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Soft Skills: Excellent written and verbal communication skills with strong project management ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Soft Skills: Excellent written and verbal communication skills with strong project management ...
Chicago, IL · On-site
$90K - $120K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Strong project management skills and the ability to execute on project plans in a fast-paced ...
Chicago, IL · On-site
$90K - $120K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Strong project management skills and the ability to execute on project plans in a fast-paced ...
Chicago, IL · On-site
$80K - $100K/yr
This critical role encompasses the management of denials and appeals both pre-payment and post ... projects, Third Party Billing Vendor, and internal Tempus teams. * Proven track record of ...
Chicago, IL · On-site
$80K - $100K/yr
This critical role encompasses the management of denials and appeals both pre-payment and post ... projects, Third Party Billing Vendor, and internal Tempus teams. * Proven track record of ...
$80K - $100K/yr
This critical role encompasses the management of denials and appeals both pre-payment and post ... projects, Third Party Billing Vendor, and internal Tempus teams. * Proven track record of ...
$80K - $100K/yr
This critical role encompasses the management of denials and appeals both pre-payment and post ... projects, Third Party Billing Vendor, and internal Tempus teams. * Proven track record of ...
New York, NY · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
New York, NY · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
New York, NY · On-site +1
$95K - $150K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Ability to work independently, communicate proactively, manage multiple projects and prioritize ...
New York, NY · On-site +1
$95K - $150K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Ability to work independently, communicate proactively, manage multiple projects and prioritize ...
Chicago, IL · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
Chicago, IL · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
Redwood City, CA · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
Redwood City, CA · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Proactively communicate project status, risks, and mitigations to partners, and manage expectations ...
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Proactively communicate project status, risks, and mitigations to partners, and manage expectations ...
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
Chicago, IL · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
Chicago, IL · On-site +1
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
Chicago, IL · On-site
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
Chicago, IL · On-site
$120K - $165K/yr
... management of Tempus' assay products, including medical devices and lab developed tests (LDTs ... Experience working in a fast-paced project core-team environment * Excellent oral and written ...
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
$190K - $260K/yr
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real ... Able to prioritize and manage several projects simultaneously. Ideal candidates will possess:
What are the key skills and qualifications needed to thrive as a Project Manager, and why are they important?
What are some common challenges faced by project managers when leading cross-functional teams, and how can they be addressed?
What is project management?
What is the difference between Project Management vs Business Analysis?
| Aspect | Project Management | Business Analysis |
|---|---|---|
| Primary Focus | Planning, executing, and closing projects | Identifying business needs and solutions |
| Certifications | PMP, CAPM | CBAP, CCBA |
| Work Environment | Project teams across industries | Business units, consulting |
| Industry Usage | Construction, IT, manufacturing | IT, finance, healthcare |
While project management focuses on delivering projects on time and within scope, business analysis centers on understanding business needs and defining solutions. Both roles often collaborate but serve distinct functions in project success and organizational improvement.
What is it like to work 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 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
Experience with complex medical devices, such as some combination of:
Genomics
NGS
Software and artificial intelligence based devices
Clinical decision support software
Oncology
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
Lifecycle management of medical devices/IVDs
Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions
Relevant sections of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA
Strong communication, presentation. and interpersonal skills
Experience guiding 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
PhD preferred.
Minimum of 2+ 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
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.