Dr. Wolfgang Klein

• full responsibility for Post Marketing Surveillance activities under IVDR and other applicable national regulations. • Vigilance responsibility for the assessment on potential adverse events and global authority communication as required. • evaluation for the initiation of Field Corrective Actions as required. • responsibility as safety officer according to German Gentechnique regulations. • member of the product complaint review board.

• leading assay development lab incl. responsibility for employees and budget. • deputy function for the head of Assay Development • Project Management • ensure R&D compliance with EN ISO 14971 and 62366, incl. definition of SOPs

Deputy project leader of the InnoNet Project „High-Throughput methods in genetic diagnostics“. Funding by the German Federal Ministry of Economics. Joint project involving several university research teams and small-to-mid sized companies.

Human Frontier in Science Project on • Cold shock response of Bacillus subtilis • Transition state regulators in Bacillus subtilis. Member of the SFB 395 „Interaction, adaptation and catalytic abilities of soil microorganisms“ as well as in the German Science Foundation (DFG) topic program „Regulatory network in bacteria“.

Post-Doc project on : "Structure-function relation and regulation in the dipeptide-chemotaxis of Escherichia coli"; funding by the National Institutes of Health (NIH), USA.

Focus on microbiology, molecular biology and biochemistry. Diploma thesis in microbiology. PhD Degree: Dr. rer. nat. ; Thesis on genetic regulation of microbial metablism pathway.