Risk-Management Manager

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Risk Manager(medical devices background a must) Overall Responsibilities:Risk Management documentation to the Product Risk Management Process of:- Risk Management Plan- Design & Clinical Risk Management- Risk Management Report Functional Experience RequirementsStrong background in Product Risk Management with experience in creation, review, and approval of risk management documentation (DFMEAs and PFMEAs)Experienced in ISO 14971Two or more years' experience in the design and development of medical devices or pharmaceuticals preferred.Strong analytical skills.Practical experience in a medical device Regulatory Environment, preparing Design Dossier submissions and preparation of Technical Files is beneficialKnowledge of European Medical Device regulations is preferred; in addition, knowledge of US medical device regulations is beneficialRequired Degree/Certificates:BS in Engineering (or science) requiredCompetencies:Proficient in Microsoft Office (Excel, Word, etc.).Ability to work as a member of a team in a timeline-driven environment with limited supervision is requiredBeing detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.Specific Languages: * Fluently in German and English If you are interested in this or a similiar position please send me your updated CV to my email address: m.tvrdon(at)realstaffing.com I am looking forward hearing back from you and wishing you a great week ahead. Kind Regards,Marco TvrdonRecruitment Consultantm.tvrdon(a)realstaffing.comTel.: +41 (0) 44 588 2640 Sthree Switzerland is acting as an Employment Business in relation to this vacancy.