Regulatory Affairs Technician

B. Braun Melsungen AG; Barcelona; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the medical industry is seeking a Regulatory Affairs Technician to join their team in Rubí. The role involves ensuring compliance with regulatory standards for medical products, requiring a strong educational background in Pharmaceutical sciences and extensive experience in Regulatory Affairs. The ideal candidate will demonstrate proficiency in English and strong problem-solving skills, and will play a key role in managing product registrations and communication with global regulatory bodies.

Formación

• Master’s/Bachelor’s in Pharmacy, Biology, or Chemistry; related Master’s preferred.
• 5+ years in Regulatory Affairs in Medical Devices.
• Deep knowledge of EU MDR and Asia/Pacific regulations.

Responsabilidades

• Lead compliance with international legal requirements for new products.
• Manage regulatory aspects and change control processes.
• Assist with communication to Notified Bodies or Health Authorities.

Conocimientos

Problem-solving

Organizational abilities

Intercultural communication

Educación

Master’s or Bachelor’s degree in Pharmacy, Biology, or Chemistry

Herramientas

Digital document management tools

Descripción del empleo

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 for new products or design changes, ensuring compliance with international legal and registration standards.
• Manage regulatory aspects within your area of responsibility.
• Assist in communication and notification of new products, renewals, and modifications, and address inquiries from Notified Bodies or Health Authorities.
• Oversee change control processes related to your products.
• Manage translations of your products.
• Implement labeling requirements within your geographical area.
• Collaborate with the Center of Excellence to improve record-related processes.

Requirements :

• Master’s or Bachelor’s degree in Pharmacy, Biology, or Chemistry; a related Master’s degree is highly valued.
• At least 5 years of experience in Regulatory Affairs within the Medical Devices industry, with cross-functional team experience.
• Deep knowledge of global Medical Devices regulation, especially EU MDR and regulations for Asia/Pacific regions.
• High proficiency in English; additional languages like German are valued.
• Project management experience is preferred.
• Proficient in digital document management and communication tools.
• Strong problem-solving skills and organizational abilities, including multitasking and documentation.
• Intercultural communication skills, particularly with Asian countries such as China, Korea, or Japan, are valued.
• Team spirit and leadership qualities.
• High ethical standards.

If your experience and interests align with this opportunity, we encourage you to apply!