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Senior Device Development Manager - Munich - Oferta z Jobs.pl

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Senior Device Development Manager - Munich

Nr ref.: /JOBS.pl

  • My client is looking to hire a:

    Senior Device Development Manager

    They are a young consultancy company, started in 2014 with a focus on supporting product development and compliance projects in the medical device and pharma/biotech industries.


    Preparation of development, quality and regulatory documents in compliance with regulatory standards
    Developing/compiling Technical Files and Design Dossiers
    Management of device development projects
    Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance
    Driving risk management activities during development and post-launch
    Performing design validation activities, e.g. planning, execution and reporting of Human Factors studies
    Consulting with customers regarding quality management and quality control challenges
    Auditing according to EN ISO 13485 and CFR 820


    Bachelor / Master in engineering or life sciences or with an equivalent combination of qualification and experience
    Knowledge of regulatory guidelines: Medical Device Directive (MDD) - Directive 93/42/EEC, CFR 820 , EN ISO 13485 and EN ISO 14971,
    Ideally with experience in the field of medical devices of at least 3 years (Master) or 5 years (Bachelor)
    Client-focused approach to work
    Excellent communication skills (verbally and in writing)
    Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and training needs
    Analytic and business-oriented thinking
    Ability to work at the client's site, as required
    Excellent command of English and German

    Please apply below or use this link for any questions.

    Apply here - applying is quick and easy on our new website


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