Manager Regulatory Submissions

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 Manager 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 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:

• Oncology IVD IUO and CDx experience required

• 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

  • Guiding cross-functional teams of subject matter experts

  • Working in a startup-like environment

  • 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 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

$110000-$150000

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. 

What We Do

We bring together one of the world’s largest libraries of multimodal clinical and molecular data with a robust suite of AI tools to help physicians personalize care in real time connect patients with therapies and clinical trials and enable partners to accelerate discovery and development of new treatments. With ~8 million de-identified research records and 350+ petabytes of data Tempus partners with more than half of U.S. oncologists and the majority of the top 20 global pharma companies. Our teams are pioneering work across oncology neurology psychiatry cardiology and beyond—transforming how care is delivered and therapies are developed. At Tempus every role contributes to our mission: to help each patient benefit from the experiences of those who came before. For more information visit tempus.com.

Why Work With Us

We’re looking for people who can change the world. People who question the status quo and refuse to shy away from tough problems. For builders who are never done building and the learners who are never done learning. Passionate individuals with undying curiosity who want to take on one of the greatest challenges humanity has ever faced—head on.

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