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Esti o parte importantă din viitorul nostru. Sperăm ca și noi suntem o parte din viitorul tău! La B. Braun, protejăm și îmbunătățim sănătatea oamenilor din întreaga lume. Poți și tu susține această viziune aducând cu tine expertiză și împărtășind inovația, eficiența și durabilitatea ca valori. De aceea dorim să continuăm să ne dezvoltăm compania împreună cu tine. Ținând cont de viitorul tău, împreună vom contribui la îngrijirea sănătății din întreaga lume cu încredere, transparență și apreciere. Asta înseamnă să împărtășim expertiza.
Post Market Surveillance Specialist
Companie:  B. Braun Shared Services Romania
Locație post:  RO-Sânandrei
Aria funcțională:  Calitate
Model de program:  Hybrid
Cerere recrutare ID:  2787

Job objective:

  • Creation, updating and transmission of vigilance reports to the competent authorities and support for the PMS system (Post Market Surveillance system) for Aesculap AG (AAG).

 

 

Responsibilities:

  • Assessing the reportability of vigilance suspicion cases
  • Reporting of vigilance cases to Competent Authorities/Notified Bodies
  • Communication with competent authorities based on vigilance cases
  • Cooperation with internal B. Braun interfaces
  • Creation of PMS reports (. Trend reports, PSUR/PMSR and PRER)
  • Participation in Quality Management projects
  • Participation in internal/external audits
  • Continuous improvement and update of defined processes
  • Contributes to "lessons-learned" procedures
  • Respects the "Code of Conduct"
  • Regular travel to AAG Tuttlingen, Germany

 

Competences:

  • Academic degree (Bachelor or Master) or comparable education;
  • Background in natural science (Pharmacy, Chemistry, Biochemistry, Biology, Medicine or related fields);
  • Working experience in Quality Management for Medical Devices (1 year) is an advantage;
  • Education in medical and/or technical writing
  • Knowledge of applicable regulations and normative standards for Medical Devices (. EN ISO 13485; EU Regulation; 21 CFR; NMPA Directives etc.);
  • Fluency in English (written and verbal); German is an advantage;
  • Microsoft Office package (. Word, Power Point, Excel) - independent user; Adobe Professional / Nuance;
  • Demonstrate a positive attitude and think in terms of solutions;
  • Works in complex structures successfully;
  • Act analytically and systematically;
  • Good organizational skills, attention to detail and capable of fast learning;
  • Excellent communication, teamwork skills and flexibility.

 

 

Benefits:

  • Unlimited period contract;
  • Annual performance bonus;
  • Work from home most of the time (80%) – Offices are 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;
  • Settlement costs for the purchase of eyeglasses;
  • Free coffee and dynamic work atmosphere.

B. Braun Shared Services Romania | Adriana Nai 
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