We are proud to introduce Cornelia Luban and Agnieszka Schreiber, who joined Qserve Group Deutschland GmbH in January, respectively in April this year.
Cornelia has a MSc degree in Biology and Physics from Humboldt University in Berlin and did her PhD at the Technical University of Berlin at the Institute of Biotechnology, Microbiology, and Genetics. During her career, she gathered extensive experience with active and nonactive medical devices, medical software, IEC 60601 and EU and global cosmetics regulations (for borderline devices between medical devices and drugs). She started her career in research at the University of Magdeburg, Center for Internal Medicine, where next to research in biological systems, she gained experience in project management, patent law, and regulatory affairs. She then moved to industry to work for Carl Zeiss as RA Manager, responsible for product approvals of ophthalmic diagnostic and therapeutic equipment for EU, US and various Asian markets. In 2013 she moved to Paul Hartmann AG, where she has been Sr. Manager RA, responsible for their technical files and global regulatory approvals as leader of RA Operations team. The broad product scope and global markets of Paul Hartmann has given her solid experience in medical device regulations but also other related regulations such as RoHS, WEEE, Cosmetics and drugs regulations regarding borderline devices.
Agnieszka has a degree in Biomedical Engineering from Cork Institute of Technology in Ireland. She adds a wealth of experience to our team, having worked across the quality system (both EU and US compliance), preparation, submission, maintenance and remediation of technical files, MDR preparation projects, and risk management. Agnieszka has sound project management skills with experience in managing cross-functional, global programs. Additionally, Agnieszka has experience with the preparation and implementation of UDI projects (US & EU). Her contribution will help us to even more efficiently support our customers in the German-speaking countries and across Europe not only to prepare for MDR and IVDR compliance but related to all Regulatory, Quality and Clinical matters.
Agnieszka about working at Qserve:
“The one thing that attracted me the most about Qserve is the practical approach – balancing business needs and regulatory compliance while maintaining a high standard of deliverables; our views are very much aligned.I am excited to have joined Qserve Group Deutschland and I look forward to engaging with existing and new customers to create rewarding experiences.”
“I look forward to having Cornelia and Agnieszka as part of our global team and help us develop and serve our client base in DACH further as well as joining in various global projects”, says Stefan Menzl, Geschäftsführer Qserve Group Deutschland GmbH
Do you find pride in supporting customers in line with professional and ethical values? Do you have a practical approach and like being creative in finding solutions? Please take a look at our career opportunities at Qserve. We would like to get in contact with you!