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.
GRA MD Junior Manager
Company:  B. Braun Shared Services Romania
Job Posting Location:  RO-Sânandrei
Functional Area:  Regulatory Affairs
Working Model:  Hybrid
Requisition ID:  5139

Job objective:

·       Supports Global Regulatory Affairs Aesculap AG Tuttlingen in registering medial devices, conducting re-registrations globally and managing the lifecycle of medical devices.

 

Tasks and Responsibilities:

  • Prepare the necessary documents for global registrations in collaboration with the Global Regulatory Affairs department of Aesculap, Tuttlingen, Germany and LRA representatives;
  • Prepare the necessary documents for re-registration with the competent authorities through local collaborators;
  • Prepare responses to deficiency notices/certifications issued by regulatory authorities;
  • Monitors registrations globally and updates databases;
  • Provides support for work tasks and specific projects GRA Aesculap, Tuttlingen;
  • Prepares the documents for the specific registration files of existing and / or newly developed medical devices, based on the information received from the internal departments of GRA Aesculap AG Tuttlingen, as the case may be;
  • Management (content, technical and format, as the case may be) of the technical documentation (TD) according to internal and external standards in the Document Management System;
  • Provides support for the activities generated by change controls;
  • Prepares specific documents following customer requests (e.g. for tenders) in collaboration with Global Regulatory Affairs Aesculap Tuttlingen;
  • Participate in GRA projects related to the improvement of processes in the department;
  • Responsible for the correctness of the information provided to managers, related departments, colleagues in charge of Local Regulatory Affairs and authorities;
  • Regular travel to B. Braun Germany (1- 2 / year) 

 

Professional competencies / Ideal candidate:

  • University degree in Medical Engineering, Pharmacy, Chemistry, Biology, Medicine or related fields.
  • Minimum 1 year professional experience
  • English - advanced, written and spoken
  • Proficient 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
  • 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 | 
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