Senior Consultant, Regulatory Affairs

Karen Hill has over 20 years of Medical Device industry experience, primarily focused on high-risk, implantable devices and In Vitro Diagnostics (IVDs). Karen’s background includes extensive experience in EU activities, such as Technical File/Design Dossier preparation, Clinical Evaluation Reports (Rev 4) and change notifications. She is one of Emergo’s leading consultants for support with European Medical Device/IVD Regulatory changes. On top of her European regulatory expertise, Karen has also cleared more than five US FDA 510(k)s and has several years of global regulatory research and strategy experience.