Job objective:

• Supports Global Regulatory Affairs Aesculap AG Tuttlingen in initiating and managing changes throughout the medical device lifecycle. Addapting technical documentation related to changes.

Tasks and Responsibilities:

• Plans, initiate and prepares the allocated variations, generated by the Change Control System, in collaboration with Global Regulatory Affairs and related departments;
• Assesses the impact of the changes according to the status of registrations globally in collaboration with the local Regulatory Affairs departments;
• Prepares the necessary documents for notifying the changes to the competent authorities; 
• Monitors the evolution of notifications and registrations globally and updates databases; 
• Formulates the responses related to the deficiencies issued by the regulatory authorities and for the requests of the local collaborators (LRA), in the context of the notification of changes; 
• Provides support for the activities generated by change control; 
• Manages (the content, technical and format, as the case may be) of the technical documentation (TD) for which it is responsible, according to internal and external standards in the Document Management System; 
• Participates in GRA projects related to the improvement of processes in the department; 
• Maintains contact with colleagues, contact persons from B. Braun (GRA and related departments), local representatives (LRA);  
• Is responsible for the correctness of the information provided to managers, related departments, colleagues responsible for Local Regulatory Affairs and authorities; 
• Documents projects, work tasks, their evolution and related deadlines according to the internally agreed model; 
• Contributes to lessons-learned procedures; 
• Complies with the "Code of Conduct". 
• Regular travel to B. Braun Germany ( up to 1- 2 / year) 

Professional competencies / Ideal candidate:

• University degree in Medical Engineering, Pharmacy, Chemistry, Biology, Medicine, IT 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:

• Undetermined contract;
• 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 |