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工作内容
Support the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU. Support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the product life cycle. Help to be compliant and to maintain the CE and ISO certificate requirements. Participate in the implementation of the new Medical Device Regulation. Support the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding company’s products, in close collaboration with marketing and sales. Attend relevant courses (internal and external) to further expand current knowledge of regulatory affairs related to EU or FDA and or non-EU regulations and willing to keep your knowledge updated by self-education/ training. Keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions. Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated. Work in close collaboration with Regulatory Affairs team.Academic Bachelor
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最后期限: 10-01-2026
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