Manager, Regulatory Submissions

Tempus AI

Manager of Regulatory Affairs at Tempus leading global regulatory strategies for FDA marketing on AI-based medical devices. Collaborating with teams to achieve business objectives in personalized medicine.

Posted 6/3/2026full-timeRemote • Illinois • 🇺🇸 United StatesMid-LevelSenior💰 $110,000 - $150,000 per yearWebsite

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Hard Skills

regulatory strategies510(k)PMADe Novo authorizationsIDEMDR CE markingsoftware validationrisk managementmachine learning validationlifecycle management

Soft Skills

strong communicationpresentation skillsinterpersonal skillsproject managementattention to detailability to work in a startup-like environmentresponsiveness to feedbackcreative problem solvingguiding cross-functional teamsexecuting project plans

Tools & Technologies

Genomics NGS Softwareclinical decision support softwarecybersecurity in medical devicesperformance studies21 CFR 820ISO 1348521 CFR 812CAPCLIAregulatory applications

Certifications & Qualifications

PhD

Industry Keywords

Oncology IVDIUOCDxmedical devicesregulatory submissionsEx-USCE MarkingUKCA registrationIVDRMDR

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Oncology IVD, IUO, and CDx experience required
Experience with complex medical devices, such as some combination of: Genomics NGS Software and artificial intelligence based devices Clinical decision support software Oncology
Experience with: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR
Software validation and risk management
Cybersecurity in medical devices
Machine learning validation requirements
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
Interacting with regulators
Ability 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
Excellent attention to detail
Strong project management skills and the ability to execute on project plans in a fast-paced environment
Scientific background PhD preferred.
Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices
Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans.

Benefits

Comp & perks

incentive compensation
restricted stock units
medical and other benefits depending on the position