Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Post Market Surveillance Specialist
Company:  B. Braun Shared Services Romania
Job Posting Location:  RO-Sânandrei
Functional Area:  Quality
Working Model:  Hybrid
Requisition ID:  2787

Job objective:

  • Planning, monitoring, and reporting vigilance cases to the competent authorities.

 

Responsibilities:

  • Performance of Post Market surveillance surveillance activities (PSUR/PMSR, PMS reports etc) based on defined processes & procedures
  • Evaluation of the reportability of suspected vigilance cases
  • Reporting vigilance cases to the competent authorities
  • Communication with the competent authorities based on vigilance cases
  • Creation and updating of Post Market Surveillance plans for the EU
  • Creation and updating of PSUR / PMSR for the EU
  • International cooperation within the Post Market Surveillance process of the Aesculap division & Berlin Vascular System
  • 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);
  • Minimum 1 year of  experience in Quality management and / or regulation for medical devices, ideal in an interface process, such as clinical evaluation, vigilance management, CAPA or change control or higher education completed in the same fields.
  • Knowledge of applicable regulations and normative standards for Medical Devices (. EN ISO 13485; EU Regulation; 21 CFR etc.)
  • Has knowledge in medical or/and technical writting;
  • Knows specific systems and applications (SAP,Bdocs e.g);
  • Fluency in English (written and verbal); German is an advantage;
  • Understanding and technical interest
  • Microsoft Office package (. Word, Power Point, Excel) - independent user; 
  • Deliver Performance & Results;
  • Learn Actively;
  • Act with Customer focus;
  • Appreciate and include different perspectives;
  • Cooperate constructively;
  • 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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