Goran Abdurrahman
Senior Ivd Product Specialist @德国莱茵TÜV集团
Signup · Get unlimited contacts
WORK HISTORY
Senior Ivd Product Specialist @德国莱茵TÜV集团
Cologne, DE
Performing technical documentation assessment for both low-risk and high-risk IVDs according to the IVDR, with expertise across a wide range of IVDs. Acted as a surrogate auditor, assessing European and international IVD manufacturers for compliance with European regulations and ISO standards. Currently leading a global team focused on technical competence in histocompatibility. Passionate about representing the notified body at international conferences and panel discussions, delivering presentations on complex and thought-provoking topics. Also skilled in training and mentoring new hires, fostering their professional development.
EDUCATION
University of Leicester
Master's degree, Infection and Immunity
Universität Greifswald
Doctor of Philosophy - PhD, Immunology
University of Sulaimani
Bachelor's degree, Biology
ABOUT GORAN ABDURRAHMAN
I\'m a regulatory affairs professional with over 12 years of experience in diagnostics, laboratory science, and regulatory affairs. Currently, I serve as a senior IVD product specialist at the notified body TÜV Rheinland, where I conduct independent conformity assessments for both low-risk and high-risk in vitro diagnostics under the EU IVDR.In my role, I focus on evaluating technical documentation and verifying compliance with regulatory requirements; ensuring that products meet the stringent standards for safety and performance before entering the European market. I also contribute to the technical leadership of our assessment team and have represented the Notified Body in international forums and conferences.In addition to my work in Europe, I’ve also been involved in training regulatory authorities across Africa, helping to build capacity and deepen their understanding of global frameworks, including the EU IVDR, WHO guidelines, and IMDRF principles.I hold a PhD in Immunology and have authored several peer-reviewed publications, combining scientific depth with a strong understanding of regulatory frameworks.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.