• Develop and execute regulatory and clinical strategies to navigate the developing regulatory environment
• Maintain expert knowledge and understanding of evolving regulations and guidelines to manage risks and develop contingency plans
• Design clinical protocols to drive multiple device development activities
• Provide regulatory oversight and approval to product development through establishment of change control procedures to assess design changes, deviations, and investigations

• Regulatory strategy and implementation for company’s first OUS Feasibility trial submissions through Investigational Device Exemption (IDE) application, CE Mark Certification, FDA audits, and Premarket Approval (PMA) application
• Regulatory strategy and FDA negotiations resulting in acceptance of an alternate primary effectiveness measurement method for the Pivotal Study and obtaining Agency agreement for clinical cohort analyses, labeling considerations, and non-clinical testing methods

• Direct responsibility for initiating and managing the first multi-center clinical study of the Chartis Pulmonary Assessment System, enrolling 97 subjects at six European centers in 12 months. The results of the study supported EU reimbursement efforts and a FDA IDE application resulting in PMA approval
• Drove publication strategy, resulting in multiple oral and poster presentations and one travel grant award at the European Respiratory Society and the American Thoracic Society

• Provided clinical and regulatory support for the EASE Trial; a randomized, sham-controlled, global study to evaluate a pulmonary drug-eluting stent utilizing Bayesian methods for study design and statistical analysis
• Prepared successful Special 510(k) for diagnostic pulmonary device
• Contributed to regulatory strategy for two separate 510(k) submissions, both of which were subsequently cleared