Senior Director/Director of Regulatory Affairs
Posted on 4/3/2024
Tempus

1,001-5,000 employees

AI-driven precision medicine through clinical and molecular data analysis
Company Overview
Tempus Labs, Inc. is a leader in precision medicine, leveraging artificial intelligence to analyze vast clinical and molecular data, enabling physicians to deliver personalized, data-driven care. The company's advanced machine learning platform and unique solution sets facilitate the discovery, development, and delivery of optimized therapeutic options for patients. With a focus on extensive molecular profiling, Tempus has developed a robust pan-cancer tumor organoid platform and validated a liquid biopsy assay, demonstrating their commitment to transforming personalized patient care and their position at the forefront of the healthcare industry.
AI & Machine Learning
Data & Analytics

Company Stage

Series G

Total Funding

$1.3B

Founded

2015

Headquarters

Chicago, Illinois

Growth & Insights
Headcount

6 month growth

7%

1 year growth

27%

2 year growth

51%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
CategoriesNew
Legal
Risk & Compliance
Legal & Compliance
Requirements
  • Experience with complex medical devices
  • Premarket Approval (PMA) applications
  • Ex-US, CE Marking, UKCA registration
  • Software validation and risk management
  • Strong communication, presentation and interpersonal skills
  • Scientific background
Responsibilities
  • Developing and leading global regulatory strategies
  • Leading submissions and correspondence with global regulatory authorities
  • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks
  • Developing and executing premarket and postmarket regulatory project plans
  • Working closely with cross-departmental subject matter experts
  • Making regular reports to the executive team