medlaQ | Consulting for medical devices

PROFESSIONAL EXPERIENCE

01/2010 – present QIAGEN Lake Constance GmbH (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

EDUCATION TRAINING

• Safety Officer for Medical Devices according to §30 MPG, Medical Mountains
• Regulatory Affairs Manager (with examination), Medical Mountains
• Quality Management Specialist (with examination), TÜV Süd
• Quality Management Representative (with examination), TÜV Süd
• Quality Management Auditor (with examination), TÜV Süd
• Thesis (magna cum laude), Universität Freiburg i.Br.
• Study Biology, Universität Tübingen, Diploma grade „very good“

OTHER SKILLS

Language skills: German (mother tongue), English (fluent / C2 level)
Computer skills: MS Office programs (good), MasterControl (good)

medlaQ - Consulting for medical devices

Dr. Bernhard Gerstenecker

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