Manager, Regulatory Affairs - Remote

Overview

The Manager, Regulatory Affairs at Tempus will play a crucial role in advancing personalized medicine by developing regulatory strategies and working with various teams to support the development of regulated medical devices.

In Short

• Develop and lead global regulatory strategies.
• Assist with submissions to global regulatory authorities.
• Establish efficient processes for regulatory compliance.
• Develop premarket and postmarket regulatory project plans.
• Collaborate with cross-departmental experts on documentation.
• Align regulatory strategy with commercial goals.
• Report regularly to the executive team.

Requirements

• Experience with complex medical devices and AI-based solutions.
• Knowledge of PMA, 510(k), IDE, CE Marking, and UKCA registration.
• Strong communication and project management skills.
• Experience in a startup-like environment.
• Scientific background with a minimum of 5+ years in Regulatory Affairs.
• Ability to evaluate device performance data.

Benefits

• Comprehensive benefits package including medical.
• Incentive compensation opportunities.
• Restricted stock units.