Regulatory Submissions Manager

1w1 week ago

Tempus

Chicago, US · Full-time · $110,000 – $150,000

About this role

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in AI technology enable meaningful impacts on clinical care. Tempus' proprietary platform connects real-world evidence ecosystems to deliver real-time, actionable insights to physicians for optimal patient treatments.

Tempus is building a regulatory team adopting creative approaches to develop regulated medical devices and secure FDA marketing authorization. The Manager of Regulatory Affairs leads global strategies supporting business objectives. This role advances personalized medicine through premarket and postmarket efforts.

Day-to-day involves leading submissions like 510(k), PMA, De Novo, IDE, MDR CE marking, and UKCA with global authorities. Establish scalable processes for multiple regulatory frameworks and execute project plans including change controls. Collaborate closely with cross-departmental experts on documentation and align strategies with commercial goals.

Work in a dynamic environment with scientists, engineers, clinicians, quality professionals, and legal teams. Report regularly to executives, operationalizing direction efficiently. Join a startup-like setting advancing precision medicine through innovative regulatory solutions.

Requirements

Experience with complex medical devices, such as genomics, NGS, software and AI-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
Experience with Ex-US regulations, CE Marking, UKCA registration, performance studies under IVDR and MDR
Experience with software validation and risk management, cybersecurity in medical devices, machine learning validation requirements
Experience with lifecycle management of medical devices/IVDs, changes triggering reporting or submissions
Familiarity with relevant sections of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA
Strong communication, presentation, and interpersonal skills; experience guiding cross-functional teams
Experience interacting with regulators in a startup-like environment; responsive to feedback with creative solutions

Responsibilities

Develop and lead global regulatory strategies to support business objectives
Lead and assist with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking
Establish processes for efficiently addressing requirements of multiple regulatory frameworks at scale
Develop and execute premarket and postmarket regulatory project plans and strategies, including assessments of change controls
Work closely with cross-departmental subject matter experts to guide creation of documentation for regulatory applications and internal records
Work closely with business leadership to ensure regulatory strategy aligns with commercial goals
Make regular reports to executive team, operationalizing leadership direction quickly and efficiently