Dietmar Schaffarczyk Email and Phone Number
Manager Regulatory Affairs International (Univ. Lübeck) ISO 13485:2016 / ISO 14971 / ISO 14155 / ISO 62366 External Auditor Medical Devices (SAQ) /Medical Writer, Clinical Investigator (EMWA)
Department Of Health Sciences And Technology (D-Hest), Eth Zürich
View- Website:
- sec.ethz.ch
- Employees:
- 165
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Dozent Eth Zürich Cas Regulatory ThinkingDepartment Of Health Sciences And Technology (D-Hest), Eth ZürichKonstanz, Bw, De -
Dozent Eth Zürich Cas Regulatory ThinkingDepartment Of Health Sciences And Technology (D-Hest), Eth Zürich Jul 2023 - PresentZürich, Schweiz -
Trainer, Coach, LecturerRegulatory Thinking® Dec 2019 - Present -
Regulatory Experts @ Eth Zurich, Dtip Clinical Trial Intervention PlatformEth Zürich Sep 2021 - PresentZürich, Schweiz -
Lead Auditor / Certification Auditor, MedtechQs International Aug 2019 - Present -
Projektleiter / Coach: Regulatory & CertificationSteinbeis Tib Technologiebewertung Und Innovationsberatung Gmbh Aug 2018 - Present
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Lehrbeauftragter / Lecturer: Medtech SchoolEberhard Karls Universität Tübingen Jun 2018 - Present -
Certified Quality Auditor (Eoq/Saq Certificate)Organisation Europeenne Pour La Qualite - European Organization For Quality Jun 2018 - Present
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External Auditor (Diplom Saq)/ Manager Regulatory Affairs, International (Univ. Lübeck)Saq Swiss Association For Quality Feb 2015 - PresentZürich Und Umgebung, Schweiz -
Member Of The Editorial BoardMedical Device Monthly News Jan 2017 - PresentZürich Und Umgebung, SchweizMedDEV News mission is to (a) introduce innovative medical technology, (b) report about regulatory requirements and (c) provide a platform for innovation and discussion.
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Managing Partner, CeoStimos Gmbh May 2015 - Present78467 Konstanz, DeutschlandstimOS GmbH transforms implant surfaces from an artificial barrier into a bone-identic implant body interface.Bioinert implant surfaces are often the reason for implant loosening or inflammatory reactions. If you have to deal with materials with weak biologic characteristics you have to change the properties and performance of an implant surface. Implants that are functionalized by stimOS GmbH with the patented Mimicking Bone Technology are no longer recognized as (exogenous) implant material in the patient’s body: Consequently inflammatory reactions can be avoided. 100-% bone in- and ongrowth is supported (bio) actively. Healing is supported. Re-operations can be avoided.
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Managing PartnerSurgesupply Gmbh Jun 2014 - PresentZürich Und Umgebung, Schweiz
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Kursleiter Regulatory Affairs & Quality Assurance (Qara)Jungchemikerforum (Jcf) Of German Chemical Society (Gdch) Aug 2018 - Oct 2023Frankfurt Am Main, Hessen, DeutschlandKursleiter Regulatory Affairs und Quality Assurance (QARA) bei der Gesellschaft deutscher Chemiker (GDCh) -
Expert / Consultant: Markteintritt, Regulatory Affairs & Mdr, Iso Standards & NormsBwcon Oct 2017 - Oct 2023StuttgartBaden-Württemberg ist eine der stärksten Wirtschaftsregionen in Deutschland und Europa. Hier existiert ein engmaschiges Netz ausgezeichneter Forschungseinrichtungen und zahlreicher industrieller Cluster auf Weltmarktniveau, die die Grundlage für die Wettbewerbsfähigkeit des Landes bilden.Baden-Württemberg: Connected e.V. (bwcon) ist die führende Wirtschaftsinitiative zur Förderung des Hightech-Standortes Baden-Württemberg mit Geschäftsstellen in Stuttgart, Freiburg und Villingen-Schwenningen. -
Managing Partner, CeoOrthobion Gmbh Nov 2010 - Dec 2014Konstanz, Deutschland
Dietmar Schaffarczyk Education Details
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Universität Zu LübeckManager Regulatory Affairs International -
Universität Zu LübeckQuality Managements Systems (Fda/Eu) -
Saq Qualicon, SwitzerlandExternal Auditor "Medical Devices" And "In Vitro Diagnostica" -
Consamed AcademyClinical Investigator, Medical Writer
Frequently Asked Questions about Dietmar Schaffarczyk
What company does Dietmar Schaffarczyk work for?
Dietmar Schaffarczyk works for Department Of Health Sciences And Technology (D-Hest), Eth Zürich
What is Dietmar Schaffarczyk's role at the current company?
Dietmar Schaffarczyk's current role is Dozent ETH Zürich CAS Regulatory Thinking.
What schools did Dietmar Schaffarczyk attend?
Dietmar Schaffarczyk attended Universität Zu Lübeck, Universität Zu Lübeck, Saq Qualicon, Switzerland, Consamed Academy.
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Dietmar Schaffarczyk
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