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    vor 10 Tagen
    D.med Healthcare Group header
    D.med Healthcare Group logo
    Vollzeit
    Mid-Level
    #healthcareinnovation#dialysiscare#sustainablehealth

    Risk Manager*in (m/f/d)

    Jetzt bewerben

    Risk Manager (m/w/d) Medical Devices

    Your responsibilities:

    • Identification, analysis, evaluation, and documentation of product and process-relevant risks for medical devices acc. to ISO 14971 and other applicable regulations
    • Evaluating the safety relevance of hazards or hazardous situations in collaboration with technical experts
    • Supporting the project teams in the technical development and implementation of risk control measures and analyzing their effectiveness
    • Supporting the identification, investigation, and GAP Analysis of regulatory requirements for medical devices
    • Supporting the creation, review, and update of technical documentation
    • Supporting the creation of market access & registration strategies for active and non-active medical devices as well as SaMD
    • Supporting the creation, review and update of Quality Management System Documentation incl. all relevant documentation
    • Supporting the regular screening of worldwide regulatory requirements

    Your profile:

    • Solid academic foundation in fields such as medical technology, engineering, computer science, or physics, or equivalent expertise through a comparable qualification.
    • Ideally 2-5 years of professional experience in  risk management, quality management and  regulatory affairs of medical devices
    • Good technical understanding of systems with mechanics, software, and hardware.
    • Good Knowledge of MDR, ISO 14971, ISO 13485, IEC 62304 and safety analysis (FMEA, FTA)
    • Excellent communication and team player skills
    • Independent and results-oriented way of working
    • Good analytical and decision-making skills
    • Fluency in German and English (written and spoken) – another language is a plus

    What we offer:

    • A diversified and challenging environment combined with a high degree of freedom for the implementation of innovative ideas
    • A permanent employment contract with performance-related pay at an international and promising employer
    • A modern workplace in spacious and bright offices in the heart of Hamburg with a view of the River Elbe
    • A supportive working atmosphere in a dynamic team with short decision paths
    • An individually tailored “on the job” training and professional development opportunities
    • Personal added values such as a company pension scheme, team events, employee discounts, bike leasing and much more

    Do you see this job offer as a personal challenge and do you want to make a difference? Then share your application, including your salary expectations and your earliest possible starting date, with us by clicking on “Apply for job”.

    We are looking forward to meeting you!

    Gehaltsschätzung

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    Max

    vor 10 Tagen

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