Remote Otter LogoRemoteOtter

Director/Senior Director, Regulatory Affairs - Remote

Posted 3 weeks ago

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.

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