Manager/Senior Manager, Regulatory Affairs - Remote

Overview

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.

In Short

• Developing and leading global regulatory strategies to support business objectives
• Leading submissions and correspondence with global regulatory authorities
• Establishing processes for efficiently addressing regulatory requirements
• Developing and executing regulatory project plans and strategies
• Working closely with cross-departmental subject matter experts
• Aligning regulatory strategy with commercial goals
• Reporting to the executive team
• Managing Quality Assurance responsibilities

Requirements

• Experience with complex medical devices
• Experience with PMA applications, 510(k)s, and IDE requirements
• Strong communication and interpersonal skills
• Experience leading cross-functional teams
• Scientific background with a Bachelor of Science or higher
• Minimum of 7+ years in Regulatory Affairs

Benefits

• Full range of benefits including incentive compensation
• Restricted stock units
• Medical and other benefits