Manager, Regulatory Submissions

Tempus AI • Chicago, IL

6d • $110,000 - $150,000

About The Position

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. 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.

Requirements

• 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
• Experience guiding cross-functional teams of subject matter experts
• Experience working in a startup-like environment
• Experience 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
• 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

Nice To Haves

• PhD preferred.

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 This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree