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Regulatory Affairs Specialist : Munich - Oferta z Jobs.pl

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Regulatory Affairs Specialist : Munich

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  • Regulatory Affairs Specialist
    Location: Munich
    Type: Permanent
    Salary: €60,000 to €70,000 per annum (dependent on experience)

    Our client is a world leader in innovative Medical Systems. With over 20 years representing medical benefit they offer a service to significantly increase the quality and efficiency of treatment.

    They are wanting to grow their Regulatory Team in Munich and looking for a Regulatory Affairs Specialist to come in and hit the ground running and strengthen the team. This is a great opportunity for someone who is dedicated, ambitious and ready for their next challenge. The successful Regulatory Specialist should want to develop in their career and be measured on results.

    Your responsibilities would include though not be limited to:
    *Monitoring of Development projects
    *Compiling registration documents for CE or FDA submissions
    *Compliance of registration documents, data and document filling systems
    *Obtaining and maintaining international approvals
    *Management duties

    Our client is looking for a Regulatory Affairs Specialist with the following experience:
    *Degree in Medical Technology, Natural Science or equivalent
    *Regulatory affairs/Quality control in Medical technology
    *Excellent organizational skills
    *A broad range of affiliate knowledge (minimum of FDA and EU)
    *3+ years Regulatory experience
    *Experience in classes I-III
    *Fluent German and English and able to read German text
    *Patient relevant device experience
    *Must be able to work in the office 5 days a week

    Keywords: Regulatory Affairs, Medical Devices, Submissions, FDA, EU, US, Quality control, Registration documents, Class I-III, Munich, Germany.


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