Job Objective
Supports Global Regulatory Affairs Avitum / Infection Prevention / B. Braun Medical AG with medical devices’ registrations and corresponding life cycle activities.
Tasks And Responsibilities

• Prepare 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 Candidate

• University 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.
  

Benefits

• Fixed-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 |
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