Sven Bajorat

Sven Bajorat Email and Phone Number

Bereichsleitung Quality Management und Regulatory Affairs @ EUROIMMUN
Hamburg, HH, DE
Sven Bajorat's Location
Greater Hamburg Area, Germany, Germany
Sven Bajorat's Contact Details

Sven Bajorat work email

Sven Bajorat personal email

n/a
About Sven Bajorat

Experienced leader of larger Quality and Regulatory Affairs organizations with many years of experience in the Medical Device / In-Vitro Diagnostics industry. Next to leadership & general management experience I am skilled in all aspects of Quality Management and Regulatory Affairs, fulfilling requierements of international standards and regulations and getting organizatons and products certified, Particular experience includes Medical Device Regulation (MDR), In-Vitro Diagnostics Regulation (IVDR), ISO13485, ISO9001, ISO14001, ISO45001, FDA, Clinical Affairs, MDSAP, Artificial Intelligence Act and the use of artificial intelligence for medical device software, mobile health applications, computer system validation (CSV) and professional project management (PMP-certified).

Sven Bajorat's Current Company Details
EUROIMMUN

Euroimmun

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Bereichsleitung Quality Management und Regulatory Affairs
Hamburg, HH, DE
Sven Bajorat Work Experience Details
  • Euroimmun
    Bereichsleitung Quality Management Und Regulatory Affairs
    Euroimmun
    Hamburg, Hh, De
    View
  • Euroimmun
    Bereichsleitung Quality Management Und Regulatory Affairs
    Euroimmun Apr 2021 - Present
    Lübeck, Schleswig-Holstein, De
    View
  • Significon Ag
    Deputy Chairman Of The Supervisory Board
    Significon Ag Dec 2013 - Present
    Mainz, Rheinland-Pfalz, De
    View
  • Dräger
    Head Of Quality & Regulatory Affairs Region Europe
    Dräger Oct 2005 - Apr 2021
    Lübeck, Schleswig-Holstein, De
    Responsibilities include establishing and maintaining Integrated Management Systems, ISO9001, ISO13485, ISO14001, OHSAS18001 certifications, Multisite certifications, Product Quality, Auditing (certified Auditor), Computer System Validation, Project Management (PMI certified Project Manager), Sales & Service Processes, Standards Implementation and Management, KPIs, Product Approvals (Regulatory)
    View
  • Dräger
    Business Process Consultant
    Dräger Feb 2003 - Oct 2005
    Lübeck, Schleswig-Holstein, De
    View
  • Accenture
    Analyst
    Accenture Jul 2001 - Feb 2003
    Dublin 2, Ie
    View

Sven Bajorat Skills

Quality Management Management Project Management Pmp Iso Business Strategy Auditing Medical Devices Cross Functional Team Leadership Change Management Iso 13485 Team Leadership Business Process Visio Customer Service Management Consulting Iso 9000 Product Development Product Management Strategic Planning Business Process Improvement Business Development Process Improvement Quality Assurance Strategy

Sven Bajorat Education Details

  • Universität Witten/Herdecke
    Universität Witten/Herdecke
    Economics
  • Project Management Institute
    Project Management Institute
    Project Management
  • Technische Hochschule Lübeck
    Technische Hochschule Lübeck
    Regulatory Affairs
  • Tohwa University
    Tohwa University
    International Exchange And Japanese Language Program
  • Uc Santa Barbara
    Uc Santa Barbara
    International Programs Extension

Frequently Asked Questions about Sven Bajorat

What company does Sven Bajorat work for?

Sven Bajorat works for Euroimmun

What is Sven Bajorat's role at the current company?

Sven Bajorat's current role is Bereichsleitung Quality Management und Regulatory Affairs.

What is Sven Bajorat's email address?

Sven Bajorat's email address is sv****@****ger.com

What schools did Sven Bajorat attend?

Sven Bajorat attended Universität Witten/herdecke, Project Management Institute, Technische Hochschule Lübeck, Tohwa University, Uc Santa Barbara.

What skills is Sven Bajorat known for?

Sven Bajorat has skills like Quality Management, Management, Project Management, Pmp, Iso, Business Strategy, Auditing, Medical Devices, Cross Functional Team Leadership, Change Management, Iso 13485, Team Leadership.

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