Job objective:

• Supporting Global Regulatory Affairs Hospital Care (HC) / Infusion and Pain Therapy / RA International team in registering medical devices and managing changes and labelling updates throughout the medical device lifecycle. 

Tasks and Responsibilities:

• Plans and prepares the allocated variations, generated by the Change Control System in B.Docs, 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 and taking into account the documentation available in B.Docs;  

• 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 local collaborators (LRA), in the context of global records;  

• Provides support for the activities generated by change control;  

• Provides support for the work tasks and projects specific to the delegated RA;  

• Updating the requirements regarding product labeling and providing the necessary support in order to prepare specific requests for label updates, in collaboration with the Global Regulatory Affairs departments;  

• Prepares the documents for the specific registration files of existing or newly developed medical devices, based on the information received from the internal departments of B. Braun, as the case may be;  

• Manages (the content, technical and format, as the case may be) of the technical documentation (TD) for which he/she is responsible, according to internal and external standards in the Document Management System; Participate 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; 

• Comply with the "Code of Conduct".

Professional competencies / Ideal candidate:

• University degree in Pharmacy, Chemistry, Biochemistry, Biology, Medicine, Medical Engineering or related fields.  
• 1 year professional experience constitutes an advantage
• English - advanced, written and spoken
• Experienced 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
• Intercultural competence 
• 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 |