Logo
Tempus AI Inc.

Manager of Regulatory Affairs

Tempus AI Inc., Chicago, Illinois, United States, 60290


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 Senior Manager/Associate 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 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:

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

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, 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 5+ years of experience in Regulatory Affairs related to medical devices

Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

#J-18808-Ljbffr