Job Objective

• Supports Global Regulatory Affairs Aesculap AG Tuttlingen in registering medial devices, conducting re-registrations globally and managing the lifecycle of medical devices.
  

Tasks And Responsibilities

• Prepare the necessary documents for global registrations in collaboration with the Global Regulatory Affairs department of Aesculap, Tuttlingen, Germany and LRA representatives;
• Prepare the necessary documents for re-registration with the competent authorities through local collaborators;
• Prepare responses to deficiency notices/certifications issued by regulatory authorities;
• Monitors registrations globally and updates databases;
• Provides support for work tasks and specific projects GRA Aesculap, Tuttlingen;
• Prepares the documents for the specific registration files of existing and / or newly developed medical devices, based on the information received from the internal departments of GRA Aesculap AG Tuttlingen, as the case may be;
• 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;
• Prepares specific documents following customer requests (e.g. for tenders) in collaboration with Global Regulatory Affairs Aesculap Tuttlingen;
• 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;
• Regular travel to B. Braun Germany (1- 2 / year)
  

Professional Competencies / Ideal Candidate

• University degree in Medical Engineering, Pharmacy, Chemistry, Biology, Medicine, Engineering or related fields.
• Minimum 1 year professional experience
• English - advanced, written and spoken
• Proficient in MS Office applications, Outlook, Adobe Professional / Nuance
• SAP - constitutes an 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
• Willing to travel internationally.
  

Benefits

• Fixed-term contract for 2 years;
• Annual performance bonus;
• Work from home half of the time (50%) – 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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