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Dr. Ursula M. Zielke

PhD , MBA

Occupational Skill & Experience

  • University degrees in Molecular Biology, Psychology and Business Management / PhD, MBA
  • Member of Novartis Steering committees
  • Regulatory & Quality Lead in Novartis International mergers and related product line sales
  • Head Regulatory Affairs EMEA & APAC, CIBA Vision
  • EC Authorized Representative (MDD / MDR), CIBA Vision
  • Member of CIBA Vision GmbH Senior Leadership Team
  • Senior Counsel Quality and GMP Compliance, CIBA Vision
  • Director Regulatory Affairs Alcon EMEA & Regulatory Affairs Head WaveLight
  • Director Novartis Emergency Mgmt, CIBA Vision
  • Compliance Officer, CIBA Vision
  • Project Management, Ethicon / Johnson & Johnson
  • Head Project & Development Coordination, Plantorgan & G.E.N. Therapeutica
  • Laboratory Manager Anticoagulation R&D, Plantorgan

Scope of Consulting & Areas of Expertise

  • Regulatory Affairs Strategy
  • Private Labeling
  • Quality & GMP Compliance
  • Business Compliance
  • Mergers
  • Health Authority & Notified Body Relations
  • Company Representation at DIN & ISO

International Collaboration (selection)

Companies / Company Sizes

  • As Novartis Associate (> 20 Years)

Lawyers: US Partners / Freshfields, Germany / Göhmann, Germany / Wolpert, Germany

European Commission // Novartis: M&A, Patents & IP, Consumer Health, Pharma // Alcon Mgmt // Alcon WaveLight // Alcon CIBA Vision // THÉA, France // Vivacta, UK // SMI, Germany // IOLTech, France // Mentor Surgical, USA // Wesley Jessen, USA // EUROSPEC, Germany // Novartis 3rd Party Distributors, Worldwide

  • Former Companies

Ethicon (Johnson & Johnson) // Plantorgan // G.E.N. Therapeutica //

  • Representation of and collaboration with Multinational Companies // Small and Medium-sized Enterprises // Non-profit Organizations

Organizations, Authorities, Countries

  • ISO // DIN
  • BSI // DEKRA // TÜV // KEMA // LGA // SGS
  • European Competent Authorities & Medicine Agencies, e.g. BfArM, ZLG, MHRA, AFSSAPS, INFARMED // US FDA // Asian Health Authorities // European Consumer Associations // European Governmental Associations
  • Germany & and all other EU Countries // EEA // EFTA // USA // Canada // South America // North & South Africa // Asia // Pacific // Australia

Professional Credentials

  • Chair of DIN panel of experts (ophthalmic optics)
  • Member of ISO panel of experts (ophthalmic optics) – German Delegate
  • ZLG panel of experts for Medical Device Biocompatibility Testings
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