Descripción del puesto

Eres una parte importante de nuestro futuro. ¡Esperamos ser también parte de su futuro! En B. Braun, protegemos y mejoramos la salud de las personas en todo el mundo. Tú apoyas esta visión, aportando experiencia y compartiendo la innovación, la eficiencia y la sostenibilidad como valores. Por eso nos gustaría seguir desarrollando nuestra empresa contigo. Teniendo en cuenta tu futuro, estamos haciendo una contribución conjunta a la atención médica en todo el mundo, con confianza, transparencia y reconocimiento. Eso es Sharing Expertise.

Regulatory Affairs Technician
Empresa:  B. Braun Surgical, S.A.U.
Ubicación del puesto:  Rubí, Barcelona, Spain
Área funcional:  Regulatory Affairs
Modelo de trabajo:  Híbrido
ID de la demanda:  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