Dipl.-Ing. Peter Schrutka-Rechtenstamm

ist offen für Projekte. 🔎

Angestellt, Principal Consultant, Entourage GmbH

München, Deutschland

Fähigkeiten und Kenntnisse

Global Regulatory Affairs for medical devices
Quality Management
General Management
Start-Up companies
management of global teams

Werdegang

Berufserfahrung von Peter Schrutka-Rechtenstamm

  • Bis heute 1 Jahr und 2 Monate, seit Mai 2023

    Principal Consultant

    Entourage GmbH

    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

Interessen

Professional contacts in Regualtory Affairs
Quality Management
Lean Startup
innovations in medical device area

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