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Regulatory affairs technician

Rubí
B. Braun Melsungen AG
Publicada el 3 julio
Descripción

Regulatory Affairs Technician

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.

- 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!

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