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 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. • 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 • Working 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.