Andreas Konrad
Regulatory Affairs Manager at PETER BREHM GmbH- Claim this Profile
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Bio
Experience
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PETER BREHM GmbH
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Germany
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs Manager
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Nov 2018 - Present
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Qualitätsmanager / Regulatory Affairs Manager
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May 2015 - Apr 2018
Qualitätsmanagementbeauftragter: Qualitätsmanagement, Regulatory Affairs, Risikomanagement, Klinische Bewertung, Technische Dokumentation, QM-Handbuch; Umsetzung der ISO 13485 und der 93/42/EWG; Auswertung und Bearbeitung von Meldungen, Berichten, Reklamationen und Vorkommnissen und daraus folgende korrigierende und präventive Maßnahmen (CAPA); Post-Market Surveillance / Post-Market Clinical Follow-Up Qualitätsmanagementbeauftragter: Qualitätsmanagement, Regulatory Affairs, Risikomanagement, Klinische Bewertung, Technische Dokumentation, QM-Handbuch; Umsetzung der ISO 13485 und der 93/42/EWG; Auswertung und Bearbeitung von Meldungen, Berichten, Reklamationen und Vorkommnissen und daraus folgende korrigierende und präventive Maßnahmen (CAPA); Post-Market Surveillance / Post-Market Clinical Follow-Up
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Post Doc / Wissenschaftlicher Mitarbeiter
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Aug 2009 - Dec 2013
• planning and management of projects• quality assurance (data management, documentation, setting up and monitoring of SOPs)• research assistant within an interdisciplinary BMBF-funded prospective diagnostic clinical study (BMBF = German Federal Ministry of Education and Research) • cooperation projects with colleagues [internal: cooperations partners of different institutes and departments of the University; external: cooperations partners of industry (e.g. Siemens) and other Universities]• academic and research teaching: academic lectures, seminars and practical courses; supervision of students and PhD students• supervision of technical employees• writing of scientific publications of project / research reports• acquisition of third party funds
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PhD student / Doktorand / wissenschaftlicher Mitarbeiter
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Aug 2004 - Jul 2009
• molecular biology, protein biochemistry, cell biology• data acquisition, data management, data documentation • high throughput analysis of gene functions via cell chip analysis (reverse transfected cell array)• operation and support of large lab equipment• talks and poster presentations on national and international congress• participation on diverse workshops
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Education
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2014 -
WBS Training AG
Consultant of project and quality management, project and quality management -
2014 -
DEKRA
Quality Management Representative, 95% -
1994 - 2002
Universität Stuttgart
Certified Biologist, technical orientated (Diplom Biologe, technisch orientiert), Technical Biology (Technische Biologie)
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