Regulatory Affairs Director
4 weeks ago
Regulatory Affairs Director
Tempus is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and executing global regulatory strategies to support business objectives.
Key Responsibilities:
- Develop and execute global regulatory strategies to support business objectives
- Lead and assist with submissions and correspondence with global regulatory authorities
- Establish processes for efficiently addressing the requirements of multiple regulatory frameworks at scale
- Develop and execute premarket and postmarket regulatory project plans and strategies
- Work closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records
- Work closely with business leadership to ensure regulatory strategy aligns with commercial goals
Requirements:
- Experience with complex medical devices, such as software and artificial intelligence-based devices, clinical decision support software, medical imaging, and premarket approval applications
- Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans
- Strong project management skills and ability to execute on project plans in a fast-paced environment
- Scientific background with a Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred
- Minimum of 7+ years of experience in Regulatory Affairs experience related to medical devices
About Tempus:
Tempus is a leading healthcare technology company that is revolutionizing the way healthcare is delivered. We are committed to advancing personalized medicine and improving patient outcomes.
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