04/2018 – present
Freelance consultant
• e.g. for Johner Institut (2018 – 11/2021)
• medlaQ (from 12/2020 until today)

04/2023- 08/2024 Johner Institut GmbH
Employed consultant (80%) for
• QM systems
• IVD

12/2021- 03/2023 Johner Medical GmbH
Employed consultant (80%) for
• electronic management systems
• external PRRC
• external QMB

01/2010 – 12/2020 QIAGEN Lake Constance GmbH (today DIALUNOX) (Stockach/Germany)
Quality Manager, Regulatory Affairs Manager, Marketing
Sector: Medical Instrument Industry (In vitro-Diagnostics), Life Sciences
• Maintenance and Optimization of QM System
• Management of Product Approvals and Product Registrations
• Performance of Risk Management
• Presentations at International Congresses and Workshops

01/2000 – 12/2009 Milenia Biotec GmbH (Gießen/Germany)
Head of R&D Department, Quality Manager, Regulatory Affairs Manager
Sector: Medical Devices (In vitro-Diagnostics)
• Development, Validation, Manufacturing and QC Testing of rapid tests (Lateral Flow Assays) and other IVDs
• Installation, maintenance and optimization of the QMSystems
• Management of product approvals and product registrations
• Safety Officer for Medical Devices according to §30 Medical Device Law

10/1996 – 12/1999 DPC Biermann GmbH (Bad Nauheim/Germany)
Head of R&D Department „Infectious and Autoimmune Diseases“
Sector: Medical Devices (In vitro-Diagnostics)
• Development, Validation, Manufacturing and QC Testing of ELISA and Westernblot Systems

04/1992 – 09/1996 Institut Virion/Serion GmbH (Würzburg/Germany)
Leader of Development Group, Scientific-Technical Product Manager
Sector: Medical Devices (In vitro-Diagnostics)
• Development of ELISA systems for infectious diseases
• Creation of marketing materials

02/1990 – 03/1992 Institut für Medizinische Mikrobiologie und Hygiene
(Universität Freiburg i.Br./Germany)
• Leader of academic working group
• Processing of funded scientific projects