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 the FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.
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 your background might look like
- Experience with complex medical devices, such as some combination of:
- Software and artificial intelligence based devices
- Clinical decision support software
- Medical imaging
- Oncology
- Cardiology
- 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, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards
- Strong communication, presentation and interpersonal skills
- Experience leading 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
- Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred.
- Minimum of 5+ years of experience in Regulatory Affairs related to medical devices
- Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans