About Tempus
Transforming healthcare with data-driven insights
Key Highlights
- Largest library of clinical and molecular data in the world
- Headquartered in Chicago, Illinois
- Over $1 billion raised from top-tier investors
- 1,000+ employees dedicated to healthcare technology
Tempus, headquartered in Chicago, Illinois, is a technology company that has developed the largest library of clinical and molecular data, focusing on oncology. With over 1,000 employees, Tempus partners with leading healthcare institutions to provide data-driven insights and personalized treatment ...
🎁 Benefits
Tempus offers competitive salaries, equity options, generous PTO, flexible remote work policies, and comprehensive health benefits, including parental...
🌟 Culture
Tempus fosters a culture of innovation and collaboration, emphasizing data-driven decision-making and a commitment to improving patient outcomes throu...
Director Of Regulatory Affairs • Senior
Overview
Tempus is hiring a Director of Regulatory Affairs to lead global regulatory strategies for medical devices. You'll work closely with scientists, engineers, and legal teams to ensure compliance with regulatory frameworks. This role requires significant experience in regulatory affairs.
Job Description
Who you are
You have extensive experience in regulatory affairs, particularly in the healthcare or medical device sectors. Your background includes developing and leading regulatory strategies that align with business objectives, and you are adept at navigating complex regulatory environments. You possess strong communication skills, enabling you to collaborate effectively with cross-functional teams, including scientists, engineers, and legal professionals. You understand the importance of precision medicine and are committed to advancing healthcare through innovative regulatory approaches.
You have a proven track record of leading submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, and UKCA marking. Your ability to establish efficient processes for addressing multiple regulatory frameworks at scale is a key asset. You are detail-oriented and have a strong understanding of the requirements necessary for successful regulatory applications.
What you'll do
In this role, you will develop and lead global regulatory strategies to support Tempus' business objectives. You will be responsible for leading submissions and correspondence with regulatory authorities, ensuring that all documentation meets the necessary requirements. You will establish processes that allow for efficient navigation of various regulatory frameworks, enabling the company to advance its innovative medical devices.
You will work closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications. Collaborating with business leadership, you will ensure that the regulatory strategy aligns with commercial goals, making regular reports to the executive team to operationalize leadership direction quickly and efficiently. Your role will be pivotal in supporting the development of regulated medical devices and seeking marketing authorization from the FDA.
What we offer
At Tempus, you will be part of a team that is at the forefront of precision medicine. We offer a collaborative work environment where your contributions will directly impact the healthcare industry. You will have the opportunity to work with cutting-edge technology and innovative approaches to regulatory affairs. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds.
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