Regulatory Affairs Specialist

Tempus AI•Chicago, IL

11d•Remote

About The Position

Tempus is building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Regulatory Affairs Specialist 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
PhD preferred.
Minimum of 2+ 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

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