Job objective:

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

Tasks and Responsibilities:

• Handles enquiries from industrial and customer sectors:

• Manages questions and requests from industrial clients, customers and for tenders, ensuring prompt and accurate responses.
• Requests and provides the required notarizations, legalizations and Certification (e.g. Free Sale Certificate);

• Prepares and coordonates independently, as well as collaboratively with the internal departments of B. Braun, the documents for the specific international registration files of existing or newly developed medical devices, within a defined product and country scope, as the case may be;  

• Prepares and regularly updates the registration dossiers tailored to the requirements of specific countries, ensuring compliance within the defined product and country portfolio;  
• Maintains and coordinates the registration status and the registration planning by updating all relevant internal databases, based on submitted documents and received registration approval, for the assigned product and country. Keeps all relevant interfaces informed and ensures timely completion of all registration activities;
• Manages the internal SharePoint by being the RA site owner (adds new colleagues, updates guidelines etc.); 
• Creates and updates the Declarations of Conformity and assures storage in the relevant databases;
• Manages the application and approval process of Basic Unique Device Identifiers (B-UDI) within SAP systems;
• Applies and provides support for procurement of Certified Documents and Translations both internally and externally and where required, organizes and coordinates translations for regisration activities, tender and customer or industrial enquiries;
• Provides support for MSDAP (Medical Device Single Audit Program) Audit by maintaing an overview with new registered products in MDSAP countries and an overview with the submitted documents to the notified body;

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

• 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;
• 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;  

• Professionaly contributes to lessons-learned procedures through active participation in projects aimed at process improvement within the Regulatory Affairs department or related areas;

• Comply with the "Code of Conduct".

Professional competencies / Ideal candidate:

• University degree in Pharmacy, Chemistry, Biochemistry, Biology, Medicine or related scientifical 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
• Great coordination and organisational skills, attention to detail, high level of personal responsibility and commitment, capable of fast learning and adopting new systems, independent and cros-functionally working skills
• Excellent communication, people interaction and teamwork skills, flexibility and resilience
• Intercultural competence 
• Willing to travel internationally.

Benefits:

• Unlimited period 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 |