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