Manager, Regulatory Submissions

At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Manager of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine. Responsibilities Developing and leading global regulatory strategies to support business objectives Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls Working 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 Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently What your background might look like Experience with complex medical devices, such as some combination of: Experience with: Scientific background $110,000-$150,000 The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #J-18808-Ljbffr Dormont Manufacturing Co