Специалист по регистрации медицинских изделий( Nobel Biocare Russia )

компания "nobel biocare russia" обязанности: responsible for all ra deliverable linked to the registration and certification of the medical devices in russia/eaeu/cis, collecting the registration dossier, maintenance of registrations in russia and other countries of the cis region as assigned by his/her direct manage. supporting development and execution of regulatory strategies for assigned projects for russia/cis. this will include the creation of submission dossier compilation of documentation and managing of timelines. monitoring submission timelines and timely responses to requests competent authorities or other partners involved in product registration. it also includes constant support for the development/ improvement of ra processes for efficient product registration. support change projects by providing ra impact assessments and support defining the necessary activities on local level. monitoring of the medical device legislation in russia and define and maintain an overview of the regulatory requirements and changes in the areas. support in training other departments to ensure continued compliance and timely market release in russia. accountable for regulatory compliance review and approval of product related labeling training internally on relevant procedures and requirements support audits by competent authorities as well as internal audits требования: critical education and knowledge: technical or scientific background, university degree is an advantage working knowledge of medical device legislation in russia and corresponding guidelines additional knowledge of legislation in other countries of the cis region is of advantage understanding of the european ce marking process good knowledge of quality system requirements such as iso 13485 additional knowledge of software development requirements (iec 62304 and ice 62366) as well as standards for electrical products such as iec 60601 are an advantage. sap critical skills: fluent in russian and english (writing, reading and speaking), further languages are an advantage highly organized and able to work under deadlines strong interpersonal skills and proactive working attitude in a international matrix organization excellent writing and communication skills critical experience: minimum 3 years experience in regulatory affairs within the medical device industry in russia understanding of eu medical device regulations условия: health and life insurance fitness allowance annual bonus