Hiring: Manager, Regulatory Submissions (Remote) Company: Tempus AI Location: Chicago, IL Job Posted Time: 2026-09-03 11:17:22 Target Skills & Keywords : AI, Machine Learning, Project Management, Risk Management About the job Experience: •5+ years of experience in Regulatory Affairs experience related to medical devices Required Skills: •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 Qualifications: •Lifecycle management of medical devices/IVDs •Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions •Relevant sections of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA •Strong communication, presentation. and interpersonal skills •Guiding cross-functional teams of subject matter experts •Working in a startup-like environment •Demonstrated capacity to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas •Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs •Strong project management skills and the ability to execute on project plans in a fast-paced environment •Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices Compensation: •$110,000 - $150,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!