Join to apply for the Regulatory Affairs Technician role at B. Braun Group .
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 to ensure compliance with international legal and registration requirements.
* Manage regulatory aspects within your area of responsibility.
* Coordinate communication and notification of new products, renewals, and modifications, and address queries from Notified Bodies or Health Authorities.
* Oversee change controls necessary for products under your responsibility.
* Manage translations of the products under your responsibility.
* Implement labeling requirements for products within your geographical area.
* Collaborate with the Center of Excellence to improve processes related to records management.
Requirements
* Master’s / Bachelor’s degree in Pharmacy, Biology, or Chemistry; a related Master’s degree is highly valued.
* Minimum 5 years of experience in Regulatory Affairs within the Medical Devices industry, with cross-functional team experience.
* Deep knowledge of global Medical Devices regulations, including EU MDR and international standards, especially for Asia / Pacific.
* High proficiency in English; knowledge of German is a plus.
* Project management experience is preferred.
* Experience with digital document management and communication tools.
* Problem-solving skills to achieve positive outcomes.
* Strong organizational skills, including multitasking, prioritization, and documentation.
* Intercultural communication skills, especially with Asian countries such as China, Korea, and Japan.
* Team spirit and leadership qualities.
* High ethical standards.
If your experience and interests align with this opportunity, don't hesitate to apply!
* Seniority level : Mid-Senior level
* Employment type : Full-time
* Job function : Engineering and Information Technology
* Industry : Medical Equipment Manufacturing
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