Director, Regulatory Affairs

Summary

Join Tempus, a leader in precision medicine, and become our Director of Regulatory Affairs. You will lead global regulatory strategies, manage submissions to authorities like the FDA, and establish efficient processes for multiple regulatory frameworks. This role requires close collaboration with scientists, engineers, and other teams to ensure regulatory compliance. You will need extensive experience in medical device regulation, including premarket and postmarket activities. A strong scientific background and excellent communication skills are essential. Tempus offers a competitive salary and a full range of benefits.

Requirements

• Experience with complex medical devices, such as some combination of Software and artificial intelligence based devices
• 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
• Analytical and clinical validity for diagnostics
• Changes to medical devices 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 10+ 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 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
• Managing and transitioning Quality Assurance responsibilities, e.g., internal and external audits, documentation of compliance with Quality and Regulatory requirements and Quality Management System

Preferred Qualifications

• Clinical decision support software
• Cardiology ECG based algorithms
• Medical imaging software

Benefits

• Incentive compensation
• Restricted stock units
• Medical and other benefits