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Regulatory Affairs Technician

Regulatory Affairs Technician

B. Braun Melsungen AGbarcelona, España
Hace 14 días
Descripción del trabajo

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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    Regulatory Technician • barcelona, España