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.
Regulatory Affairs Technician
Company:  B. Braun Surgical, S.A.U.
Job Posting Location:  Rubí, Barcelona, Spain
Functional Area:  Regulatory Affairs
Working Model:  Hybrid
Requisition ID:  5711

We seek to incorporate a Regulatory Affairs Technician for a vacancy in the Regulatory Affairs Department of B. Braun Surgical, S.A.U. in Rubí.

 

Functions:

- Lead or collaborate in the application of legal requirements in new products or design changes, in order to comply with all international legal and registration requirements.

- Lead the management of the regulatory aspects in their area of responsibility.-             

- Collaborating in the communication and notification of new products, renewals, and modifications, and dealing with the questions from Notified Bodies or Health Authorities.-             

- Manage or monitor the changes controls that are necessary to carry out the products under your responsibility.-             

- Manage the translations of the products under your responsibility.-             

- Manage the implementation of the labeling requirements of the products within the geographical area of responsibility       

- Collaborate with the different areas of the Center of Excellence in the continuous improvement of processes related to records.

 

Requirements:          

- Master’s/Bachelor’s degree in Pharmacy, Biology or Chemistry preferred.-           

- A Master's degree related to the Pharmaceutical Industry is highly valued.-           

- At least 5 years of Experience in Regulatory Affairs within the Medical Devices industry, working in cross-functional teams.-           

- Deep knowledge of Medical Devices global regulation, including the European (in particular EU MDR) and International (specially for Asia/Pacific region).-           

- High level of English           

- Other languages, particularly German, are valued.-           

- Project management experience is preferred.            

- Document management and communication using digital tools are required.

 

Personal Competencies:         

- High capacity of solving problems to achieve a positive result.           

- High organizational skills: ability of multitasking, task prioritization, compartmentalizing projects and documenting everything for easy access and future reference.           

- Intercultural communication with asian countries like China, Korea and/or Japan, are valued.             

- Team spirit and leadership skills. 

- High ethical values. 

 

If you think your professional experience and interests are align with the offer, dont hesitate to apply!

B. Braun Surgical, S.A.U. | Victoria Merodio 
Apply now