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Being goal-oriented and able to think outside the box, I have the ability to come up with efficient solutions for any problem.


Dr. Katharina Sophie Neuhäuser

SCIENTIFIC, REGULATORY & QUALITY EXPERT


TOP SKILLS: Post-Market Surveillance (PSUR/PMSR/PMCF), Clinical Study Planning, Biological Evaluation


Why PRO-LIANCE
Even before I started to study biotechnology, I was fascinated by cancer research, because I always wanted to contribute to improving people's health. After completing my PhD in biomedicine and my postdoctoral work to this field, I found my way to PRO-LIANCE, where I can now pursue this desire in all imaginable areas in order to make medical devices safer.

Challenge
The broad range of medical devices available requires you to be able to grasp new topics quickly and accurately in order to understand the properties of each individual product. Challenge accepted.

My strengths
Even while I was still a student, I would already identify errors in text books. I have the ability to identify complex patterns and inconsistencies quickly. This allows me to optimally prepare our clients for audits with notified bodies. As a result, they will already have everything sorted out for the approval process. Delivering work of highest quality is my highest priority.

My motivation
My passion for research, as well as my natural curiosity, have accompanied me all my life. I have already lived, studied and/or worked in 3 different countries, which is why I was immediately fascinated by the diverse range of medical products available. The world of medical products includes virtually everything, ranging from plasters to X-ray machines.

Who I am
My private life is just as diverse as my work at PRO-LIANCE. I like to spend my free time playing the electric guitar, painting or in foreign countries – always capturing my impressions for eternity – both above and also under water.

Scientific, Regulatory & Quality Expert

PRO-LIANCE GLOBAL SOLUTIONS GmbH

Postdoctoral Researcher

Hannover Medical School

Dr. rer. nat. (Biomedicine)

Visiting Researcher (DAAD funding program)

The University of Western Australia

Mount Maunganui College

Bay of Plenty, New Zealand

Post-Market Surveillance (PSUR/PMSR/PMCF)

Clinical Study Planning

Biological Evaluation

Clinical Evaluation

Safety Database Researches

Data Appraisal

Equivalence Assessments

GMP/GCP/GLP

Project Management

Cancer Research & Radiotherapy

Confocal Laser Scanning Microscopy & In vivo Imaging

Languages: German, English