Regulatory Affairs Manager • Manager

Who you are

You have a strong background in regulatory affairs, particularly in the healthcare or medical device sectors. With experience leading submissions and correspondence with global regulatory authorities, you understand the intricacies of 510(k), PMA, De Novo authorizations, and CE marking. Your ability to establish processes for efficiently addressing regulatory requirements at scale sets you apart. You are adept at collaborating with cross-departmental teams, guiding the creation of documentation needed for regulatory applications, and ensuring that regulatory strategies align with commercial goals.

You possess excellent communication skills, enabling you to make regular reports to executive leadership and operationalize their direction quickly and efficiently. Your experience in developing and executing premarket and postmarket regulatory project plans demonstrates your capability to manage complex projects effectively. You are committed to advancing personalized medicine and are excited about the potential of AI in clinical care.

What you'll do

In this role, you will develop and lead global regulatory strategies that support Tempus' business objectives. You will be responsible for leading submissions and correspondence with regulatory authorities, ensuring compliance with various regulatory frameworks. You will establish processes that allow for efficient handling of regulatory requirements, working closely with scientists, engineers, and quality professionals to support the development of regulated medical devices.

You will guide the creation of necessary documentation for regulatory applications, ensuring that all submissions meet the required standards. Collaborating with business leadership, you will align regulatory strategies with commercial goals, making sure that the regulatory team supports the overall mission of the company. Regular reporting to the executive team will be a key part of your responsibilities, allowing you to operationalize leadership direction effectively.

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 be part of a mission-driven organization that is dedicated to improving patient outcomes. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds.