Director/Senior Director, Regulatory Affairs - Remote

Overview

Tempus is seeking a passionate Director of Regulatory Affairs to lead the development of regulatory strategies for medical devices, working closely with various teams to advance personalized medicine.

In Short

• Develop and lead global regulatory strategies.
• Manage submissions and correspondence with regulatory authorities.
• Establish processes for regulatory compliance.
• Execute premarket and postmarket regulatory plans.
• Collaborate with subject matter experts for documentation.
• Align regulatory strategy with commercial goals.
• Report to executive team on regulatory matters.
• Oversee Quality Assurance responsibilities.

Requirements

• Experience with complex medical devices.
• Knowledge of PMA, 510(k), and IDE requirements.
• Experience with CE Marking and UKCA registration.
• Strong communication and interpersonal skills.
• Ability to lead cross-functional teams.
• Scientific background with a degree in a relevant field.
• 10+ years of experience in Regulatory Affairs.
• Attention to detail and project management skills.

Benefits

• Competitive salary range.
• Incentive compensation.
• Restricted stock units.
• Comprehensive medical benefits.