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B. Braun Adria RSRB is established in 2011. We offer a comprehensive product portfolio for healthcare, followed by high quality service. We are proud to announce that B. Braun Adria RSRB is continuously developing business and therefore recruiting a new member in Regulatory Affairs.
Regulatory Affairs Specialist
Regulatory Affairs and Product Safety Department
Collection and preparation of registration, variation and renewal documentation for medicinal products and medical devices. Communication with national regulatory institutes and with the global regulatory office. Preparation of relevant reports. Preparation of documentation for definition of maximal price of medicinal products and for imputing of medicinal products on the list the Republic healthcare fond.
Compilation of tasks handed down by the Responsible person for Regulatory Affairs and / The Head of the Regulatory Affairs and Product Safety Department.
- Collection and preparation of registration and renewal documentation for medicinal products, medical devices and other products
- Collection and preparation of variation documentation
- Communication with the global regulatory office
- Communication with national regulatory institutes (ALIMS, Ministry of Health, RFZO)
- Preparation of documentation for approval of control labels and additional labels for medicinal products
- Preparation of documentation for gaining approval for import of non-registered medicinal products and medical devices
- Preparation of documentation for gaining approval for import of medicinal product containing controlled substances
- Preparation of reports regarding registered medicinal products and medical devices
- Continuous maintenance of the existing data base of registered products and valid documentation
- University degree: Biomedicine fields medicine, stomatology or pharmacy
- Minimum 2 years of work experience required
- Educations on the Medicinal Products and Medical Devices Act
- General knowledge of medicinal products registrations and renewals and competency to independently prepare documentation for medicinal product registration, variation and renewal
- Knowledge of medical device regulations and competency to independently prepare and submit documentation for medical device registration and renewals
- Proficiency in English language
- Competency in MS Office
The required competences for the position are based on the B. Braun Core Competencies model
- Take responsibility and shows a high commitment
- Work actively on personal progress
- Interact constructively
- Act analytically and systematically
- Act decisively in uncertain conditions
- Working in a corporate culture based on B. Braun values: Innovation, Efficiency and Sustainability
- Continuous support for your success and engagement through On-boarding and Performance management process
- Professional development: attending educations, trainings, conferences relevant for role of Regulatory Affairs Specialist
Deadline for applications: 27.02.2020.