Ms. Koeneman is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2015. She has 30 years of regulatory experience, including positions as Scientific Reviewer and Compliance Officer at the FDA Center for Devices and Radiological Health (CDRH). Her industry experience includes Director of Regulatory Affairs at Silverleaf Medical Products (Vomaris Innovations), and Senior Director of Regulatory Affairs and Regulatory Compliance Manager at OrthoLogic Corporation (Capstone Therapeutics). She has been consulting for medical device, pharmaceutical and combination biologic/device/drug companies for 18 years.
Ms. Koeneman has extensive experience managing and directing regulatory and quality assurance departments and performing due diligence for early-stage new molecular entity peptides, novel medical devices, and combination products. Her areas of expertise include development strategy, pathway to market, regulatory submissions, and compliance, and career highlights include developing and implementing strategies regarding medical devices, combination products, IDEs, PMAs, INDs, and helping to transform a medical device company into a drug development company.
In the past, Ms. Koeneman served as a guest lecturer on FDA-related regulatory topics at Arizona State University and as an engineering advisory board member at Grand Canyon University.