компания "antal russia" principal objective of position: ensure efficient registration & certification and timely conduct various business processes within department. temporary replacement due to maternity leave of permanent specialist general functions: quality support company to follow quality policy, standards and local regulations, management of product complaints from customers, timely reporting into local system, data trending; management of product complaints, timely reporting into local system, data trending; handling customer complaints; perform registration and certification/declaration processes for medical devices in russia and cis countries and work independently on each step from initialization till license obtained:a) documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources;b) registration dossier preparation;c) review product registrations for accuracy and completeness of documentation is required;d) cooperation with consultancy;e) cooperation with local business;f) cooperation with out source companies;g) responsible for accurate documentation of new products for submissions to authorities;h) ensure timely registration of all new products and obtaining of relevant licenses; support of company’s product portfolio and maintenance of registration license, amendments proceeding, change impact assessment. requirements: experience in medical device registration from 1 year; intermediate english; full cycle registration experience. benefits: medical insurance; communications; mobile phone allowance.
Адрес
Москва