Regulatory Affairs TechnicianWe 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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