Senior Director/Director of Regulatory Affairs

Passionate about precision medicine and advancing the healthcare industry?

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 Senior Director / 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 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
• Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications
• 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 devicesClinical decision support softwareMedical imagingOncologyCardiology
• Experience with : Premarket Approval (PMA) applications, de novo requests for reclassification, 510(k)s, investigational device exemption (IDE) requirementsEx-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDRSoftware validation and risk managementCybersecurity in medical devicesMachine learning validation requirementsChanges to medical devices that trigger reporting or regulatory submissionsRelevant 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 expertsExperience working in a startup-like environmentExperience interacting with regulatorsAbility to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areasResponsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needsExcellent attention to detailStrong 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 10+ years of experience in Regulatory Affairs experience related to medical devicesKnowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.