Regulatory Affairs Manager (f/m/x) for AI related Digital Medical Devices

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Arbeitgeber: Carl Zeiss AG

Jobdatum: 03. Dezember 2022

Einstiegsart: Professionals Jobs

Einsatzort: München; Bayern


Stellenbeschreibung - Regulatory Affairs Manager (f/m/x) for AI related Digital Medical Devices

connecticum Job 1588911

Regulatory Affairs Manager (f/m/x) for AI related Digital Medical Devices

Your role

Revolutionize the digital world of Carl Zeiss Meditec AG and together with our agile development teams, take a step towards the medical technology of tomorrow. Come and join our mission of driving the digital transformation of our Health Data Platform and our Medical Ecosystem.

 

As a Regulatory Affairs Manager for Digital Solutions based on Artificial Intelligence, you will significantly contribute to our worldwide submissions of our medical products and therefore play a crucial role on the development of our digital medical devices. With your broad experience in the field of international approval of medical devices, you will be responsible for taking over the central preparation of the documentation and strategy as guidance and support for submissions of the digital products in the regions and you will act as contact person for notified bodies. In your tasks and your daily business, you will be supported by our Junior Regulatory Affairs Managers within the team. Together with the team, you will also contribute to the optimization of our internal process for the regulatory strategy of digital products.

     

     

    Your Profile

    • You have completed an Engineering or medical degree or obtained a doctorate.

    • You have experiences with AI based regulations.

    • You can simplify the challenges of AI for strategical decisions for different stakeholders.

    • You have several years of working experience in the field of international approval of medical devices, ideally of digital products or services as medical devices (SaMD).

    • You love working in an interdisciplinary team consisting of product management, developers, engineers, usability specialists and of course other regulatory as well as clinical affairs specialists.

    • You are business fluent in English, and have preferably also German language skills.


    Informationen zur Bewerbung
    Stellenangebot:

    Regulatory Affairs Manager (f/m/x) for AI related Digital Medical Devices

    Jobkennzeichen:
    Connecticum Job 1588911
    Bereiche:
    Ingenieurwissenschaften: Allg. Ingenieurwissenschaften, Medizintechnik
    Kontaktdaten
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