Regulatory Affairs Expert
Cornelia is qualified and very experienced in project management conducting literature studies, technical writing and editing of medical-scientific-engineering documents, as well as Gap Analyses of all international Quality and Regulatory aspects related to many types of Medical Devices.
She is hands-on, pragmatic and knowledgeable translating the regulatory requirements to requirements for R&D, Marketing and Operations.
Cornelia has been involved in many Notified Body audits and inspections by authorities. She is experienced in project management and technical writing.
Cornelia has been working in the medical business for 10 years. Before joining Qserve, she worked in industry as Regulatory Affairs Manager at Carl Zeiss Meditec AG and later as Senior Manager Regulatory Affairs and Head of Regulatory Operations at Paul Hartmann AG, dealing with a broad range of devices (class I, II, and III), including medical software, combination devices, and implantable medical devices.
She has a broad scientific background holding advanced degrees in Biology and Physics.
Learn more about our services within Regulatory Affairs