Dipl.-Ing. Peter Schrutka-Rechtenstamm
Angestellt, Principal Consultant, Entourage GmbH
München, Deutschland
Werdegang
Berufserfahrung von Peter Schrutka-Rechtenstamm
Advisor and solution provider at all stages of medical device life cycle, for companies of all sizes (start-ups to multinational enterprises): - regulatory and clinical quick check of early product ideas - global regulatory and clinical strategies of new / changed products; - global approval/ registration planning; - production transfers (e.g. for SKD projects); - challenging compliance situations - RACA role in M&A projects
Bis heute 13 Jahre und 6 Monate, seit 2011
Lecturer "International Market Clearance of Medical Devices"
TUEV Austria Akademie
Lecturer for "International Market Clearance of Medical Devices" / "Internationale Zulassung von Medizinprodukten"
7 Jahre und 7 Monate, Okt. 2015 - Apr. 2023
Senior Director Regulatory and Clinical Affairs
Carl Zeiss Meditec AG
Head of Global Regulatory and Clinical Affairs
8 Jahre und 6 Monate, Nov. 2014 - Apr. 2023
Senior Regulatory Affairs Director
Carl Zeiss Meditec AG
Global Head of Regulatory Affairs
5 Jahre und 8 Monate, März 2009 - Okt. 2014
Regulatory Affairs Director Ultrasound
GE Healthcare Systems
3 Jahre und 8 Monate, Juli 2005 - Feb. 2009
Quality & Regualtory Affairs Leader
GE Medical Systems Kretztechnik Gmbh & Co OHG
responsible for regulatory affairs and risk management of Voluson Ultrasound products
4 Jahre und 3 Monate, Feb. 2001 - Apr. 2005
QM Manager
ADIAM life science AG
ADIAM life science AG, Erkelenz (Germany), medical device start-up company (artificial heart valve prostheses and vascular grafts). Manager for Quality Management, RA & QA project manager for IT/ERP introduction internal coach for project management Participation in VC raising.
2 Jahre und 5 Monate, Sep. 1998 - Jan. 2001
General Manager / Geschäftsführer
Deutsche VTU Engineering Gmbh
Engineering & consultancy company for process engineering (basic engineering and conceptual design) for pharmaceutical industry. Managing Director / Geschäftsführer with full managing responsibility for the company
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen