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 applying legal requirements for new products or design changes to ensure compliance with all international legal and registration standards.
Manage regulatory aspects in your area of responsibility.
Coordinate communication and notification of new products, renewals, and modifications, and address questions 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 within your geographical area.
Collaborate with the Center of Excellence to improve processes related to records.
Requirements:
Master’s/Bachelor’s degree in Pharmacy, Biology, or Chemistry;
a Master’s 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 global Medical Devices regulation, including EU MDR and international regulations, especially for Asia/Pacific.
High proficiency in English;
knowledge of German or other languages is valued.
Project management experience is preferred.
Proficiency in digital document management and communication tools is required.
Personal Competencies:
Problem-solving skills to achieve positive results.
Strong organizational skills:
multitasking, prioritization, documentation.
Intercultural communication skills, especially with Asian countries like China, Korea, and Japan, are valued.
Team spirit and leadership qualities.
High ethical standards.
If your experience and interests align with this opportunity, please apply!
Additional Details:
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Engineering and Information Technology
Industry:
Medical Equipment Manufacturing
Referrals can increase your chances of interviewing at B. Braun Group by 2x.
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Location:
Granollers, Catalonia, Spain
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