Quality assurance & regulatory affairs specialist (medical devices) - Специалист по регистрации

Our Client is an international company. Responsibilities: Perform registration process for medical devices and work independently on each step from initialization till license obtained – under national Registration Rules and under EAEU legislation procedure Ensure effective project management for product registration and re-registration in collaboration with registration consultancy Review registration documents and dossier preparation (including filing application forms and test protocols check) with expertise for registration submission directly /with consultancy Communicate with foreign manufacturers for request of product dossier for registration Coordinate all registration-related activities for project (consultancy, samples ordering, testing remarks correction to HA) Compile, coordinate and monitor renewals for medical devices in accordance with the national and EAEU legislation Maintain of registered products dossier and registration license up to date, amendments proceeding, change impact assessment Support of registration in CIS countries Manage of product complaints, timely reporting into local system, data trending. Required Knowledge and Skills: Higher / Professional education Strong knowledge of relevant medical device industry regulations Experience in conducting a full cycle of registration of medical devices is required (not medicines, not cosmetics) Experience in certification according to technical regulations, notification Knowledge of the rules of the Customs Union English – upper-intermediate Ability to accurately work with large amount of data from various sources Responsibility Attentiveness to details Time-management and problem-solving skills Ability to work effectively within a team in a fast-paced changing environment Ability to effectively communicate in English in verbal and written Result-focus Conditions: Work in a professional team International environment Professional development and career growth Fixed salary + annual bonus Voluntary medical insurance & life insurance Mobile phone.