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Regulatory Affairs Manager - Oferta z Jobs.pl

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Regulatory Affairs Manager

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  • Regulatory Affairs Manager
    Location: Hamburg, Germany
    Salary: Flexible depending on level
    Job type: Permanent, full time
    - Interested in working in both product registrations and R&D projects within class I & II medical devices?
    - Want to work for a global, stable company with top level training/development?
    - Looking to develop and implement regulatory strategy?

    Job reference: J24381
    A highly successful Medical Device company in Hamburg has recently released a Regulatory Affairs Manager vacancy, to be based from their HQ in Hamburg. This is a broad role involving regulatory strategy, product registrations and R&D Development projects. Due to the popularity of this company this role will likely move quite quickly!
    *Development of registration strategies for medical systems and new products
    *Coordination of all necessary regulatory affairs activities, including approval and maintenance, as well as coordination with the respective departments, suppliers and notified bodies
    *Ensuring compliance with regulatory requirements (MDD, FDA, PAL) in collaboration with the development departments during the product development process
    *Preparation of documentation for product approvals
    *Review and approval of development documents from the perspective of the Regulatory division
    Your qualifications
    * Profound experience in product registration of medical devices class I & II
    * Willing to work with R&D in development projects of mechanical devices
    * Knowledge of international regulatory requirements and other relevant standards
    * Excellent communication skills and fluency in both written and spoken English and German

    Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
    Key words: Regulatory, Regulatory Affairs, Medical Devices, Hamburg, North Germany, Endoscopy, Class I, Class I, Manager, Regulatory Affairs Manager


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