Jürgen Blume

Qualifications

  • Regulatory Affairs (D, EU) Pharmaceuticals, Medical Devices, IVD, Companion Diagnostics, Health Supplements (in coop with academia)
  • Market Authorisation/Market Access
  • Clinical Research (as sponsor, CRO, site)
  • Experienced lecturer in Regulatory Affairs, Clinical Research, Health Economics, Data Management, Clinical Project Management
  • Funding EU, D
  • Consultancy (e.g.) setting up and leading operations / projects
  • Developing and maintaining cooperation’s and partnerships with KOLs, corporations, institutions, administrations and public authorities
  • Developing and maintaining new and top-level networks (KOL)
  • Negotiate at all levels

Qualification Matrix

Work Experiences

Actual

(Vice-)Head Steinbeis Research and Transfer Centre Medical Devices & Biotechnology, Weinheim Director Medical Research & Regulatory Affairs

Lecturer for Regulatory Affairs, Clinical Research, Health Economics (Pharma/MD), mibeg Institute Medizin, Köln

Past

Director Medical Research & Regulatory Affairs, Immungenetics AG, Rostock

CEO / Founder, CERT Healthcare GmbH, Rauenberg, Notified Body for the Republic of Uzbekistan till 2005; below positions resulted from CERT activities
Head Clinical Studies, Study Center Heidelberg
Director Medical Research, Cegedim CSD, Bensheim
CEO, Co-founder, CONCERT Medical Optics GmbH i.G., Rauenberg
Director Business Development (COO), BioPheresis GmbH, Heidelberg
Vice President Corporate Development / Co-founder (Project Head „Medical Health Chip Card“), GCG America, Inc., Mannheim
General Manager Middle-/Eastern Europe, MedicAlert gGmbH, Ratingen
Consultancy for multilevel marketing / Medical Device Manufacturers, Freelance, Ratingen
Director New Products and M&A, Block Drug Comp., Inc., Ratingen
Business Unit Manager Europe, De Trey-Dentsply GmbH, Wiesbaden
New Product Development & Market Research Manager Europe, Mallinckrodt GmbH, Groß-Ostheim
Sales Manager Germany, Austria and Swiss, Becton-Dickinson, Heidelberg
Pharmaceutical Sales Representative / Regional Sales Manager, Merz & Co., Ffm

Memberships

  • DiagnostikNet Berlin-Brandenburg e.V., Berlin
  • European Association of Pharma Biotechnology e.V. (EAPB), Berlin
  • German Physicians Cancer Society e.V. (DKG), Berlin
  • German Society for BioMedical Techniques e.V. (DGBMT/VDI), Frankfurt
  • German Society of Regulatory Affairs e.V. (DGRA), Bonn
  • Health EBS e. V. (alumni Network European Business School)