Practice Area Focus
- Medical Devices
- Combination Products
- Orphan Drugs
- Regulatory Compliance
- Nonclinical Development Strategy
- Regulatory Operations
Ms. Koeneman joined NDA Partners as an Expert Consultant in 2015. She has more than 24 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 companies for over 11 years.
Ms. Koeneman has extensive experience managing and directing regulatory and quality assurance departments and performing due diligence for early stage new molecular entity pharmaceuticals, novel medical devices, and combination products. Her areas of expertise include development strategy, regulatory submissions, and compliance, and career highlights include developing and implementing strategies regarding medical devices and INDs, and helping to transform a medical device company into a drug development company.
Ms. Koeneman serves as a guest lecturer on FDA-related regulatory topics at Arizona State University.