Dr. Claudia Christner-Albrecht
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Claudia Christner-Albrecht
- Current 4 years and 2 months, since Apr 2022
Senior Regulatory Affairs Manager
Carl Zeiss Meditech AG
Regulatory Affairs for Medical Devices (e.g. refractive laser devices)
- 4 years and 6 months, Oct 2017 - Mar 2022
Head of Regulatory Affairs / EMEA Regulatory Affairs Programme Manager
Abbott Rapid Diagnostics
Head of Regulatory Affairs, International Registrations, WHO Prequalification, Regulatory Compliance Projects, MDD, MDR / IVDD, IVDR
- 2 years and 8 months, Feb 2015 - Sep 2017
Head of Regulatory Affairs / EMEA Regulatory Affairs Programme Manager
Alere Technologies GmbH
Regulatory Affairs in Medical Device / IVD Industry, Regulatory Affairs Compliance Projects
- 4 years and 8 months, Jun 2010 - Jan 2015
Head Quality Management / Regulatory Affairs
Alere Technologies GmbH (formerly CLONDIAG GmbH) a subsidiary of the Alere group
Quality management / regulatory affairs; responsibility for regulatory aspects in the following fields: development, registration (incl. countries in EU, AsiaPac incl. China, LA, Africa, CIS) and production of in vitro diagnostic (IVD) medical devices (incl. in controlled production rooms class 8, ISO14644), labelling, rebranding, vigillance; Implementation and maintenance of a certified QM system according to DIN EN ISO13485, WHO diagnostics prequalification, 21CFR820
- 1 year and 7 months, Nov 2008 - May 2010
Head Quality Management & Regulatory Affairs
Clondiag GmbH (a company of Inverness Medical Innovations)
Quality management / regulatory affairs; responsibility for regulatory aspects in the following fields: development, registration and production of in vitro diagnostic (IVD) medical devices; Implementation and maintenance of a QM system according to DIN EN ISO13485
- 7 years and 1 month, Oct 2001 - Oct 2008
Project Leader
Jerini AG
Senior Scientist, Project Leader and Project Manager of drug discovery and preclinical drug development projects (oncology, inflammation), Experience in in vivo models and in vitro biochemical and cell-based assays
- 1 year and 2 months, Aug 2000 - Sep 2001
Scientist
Pintex
Setup of HTS screening lab
Ausbildung von Claudia Christner-Albrecht
- 2 years and 1 month, Sep 2005 - Sep 2007
Master of Business Administration
FOM Berlin
Project Management, Licensing, Market Analysis, Competitive Analysis
- 1 year and 1 month, Aug 1999 - Aug 2000
Cell Biology
University of Mainz
Postdoc
- 6 months, Feb 1999 - Jul 1999
Biochemistry
Max-Planck Research Unit Halle
- 3 years and 2 months, Jan 1996 - Feb 1999
Enzymology
Max-Planck Research Unit Halle
High Throughput Screening, enzymatic assays, characterization of enzyme inhibitors, secondary assays
- 10 months, Sep 1992 - Jun 1993
Biology
University of Manchester
Immunology, Pharmacy, Biochemistry, Cell Biology
- 5 years and 4 months, Sep 1990 - Dec 1995
Biology
Friedrich-Schiller University Jena
Biochemistry
Sprachen
English
C1 (Fließend)
German
C2 (Verhandlungssicher / Muttersprachlich)
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