GRA MD Junior Manager 2 years

Job ObjectiveSupports Global Regulatory Affairs Avitum / Infection Prevention / B. Braun Medical AG with medical devices’ registrations and corresponding life cycle activities.Tasks And ResponsibilitiesPrepare the necessary documents for global registrations in collaboration with the Global Regulatory Affairs department / Infection Prevention and LRA representatives;Prepare the necessary documents for re-registration with the competent authorities through local collaborators;Formulate responses to notifications regarding deficiencies/requests issued by regulatory authorities;Monitor registrations globally and updates databases;Provide support for work tasks and specific projects;Provide support in compiling documents for specific files on existing and/or newly developed medical devices, based on information received from Avitum/ Infection Prevention internal departments, as appropriate;Management (content, technical and format, as the case may be) of the technical documentation (TD) according to internal and external standards in the Document Management System;Provides support for the activities generated by change controls;Assess the impact of changes based on the status of global registrations in collaboration with local Regulatory Affairs departments worldwide and taking into account the available documentation;Prepare the necessary documents for notifying the competent authorities of the changes;Prepares specific answers and documents following customer requests (e.g. for tenders) in collaboration with Global Regulatory Affairs – Avitum / Infection Prevention;Participate in GRA projects related to the improvement of processes in the department;Responsible for the correctness of the information provided to managers, related departments, colleagues in charge of Local Regulatory Affairs and authorities;Track and socument status of projects and related deadlines according to the internally agreed model;Contribution to “lessons learned” procedures;Regular travel to B. Braun Germany (1- 2 / year) .Professional Competencies / Ideal CandidateUniversity degree in Pharmacy, Chemistry, Biology, Medical Engineering, Medicine or related fields;Minimum 1 year professional experience;English - advanced, written and spoken;Proficient in MS Office applications, Outlook, Adobe Professional / Nuance;SAP - advantage;Good organisational skills, attention to detail, high level of personal responsibility and commitment, capable of fast learning and adopting new systems;Excellent communication and teamwork skills, flexibility and resilience;Intercultural skills – advantage;Willing to travel internationally.BenefitsFixed-term contract for 2 years;Annual performance bonus;Work from home most of the time (80%) – Office work takes place in Sânandrei, Timis County;Meal tickets;Health subscription (free or discounted medical services);7 Card subscription;A premium for family events, according to the Collective Labor Agreement;Partial settlement costs for the purchase of eyeglasses;Free coffee and dynamic work atmosphere.B. Braun Shared Services Romania | Adriana Nai |