Técnico/a I+D – Regulación de Productos Sanitarios

About the role

We are expanding our team and are looking for a motivated R&D Technician to specialize in the regulatory affairs of medical devices. The successful candidate will work within the R&D department, closely collaborating with the Quality team to ensure all products meet the European Medical Device Regulation (MDR) requirements.

Key responsibilities

• Prepare, update and maintain technical documentation required for MDR compliance.
• Develop Clinical Evaluation Reports (CER) and Periodic Safety Update Reports (PSUR).
• Manage risk assessments, usability engineering studies, and Summary of Safety and Clinical Performance (SSCP) documents.
• Assemble and maintain the Technical File (TF) and support Post‑Market Surveillance (PMS) activities.
• Coordinate with the Regulatory Affairs team to ensure timely submissions and approvals.

Required profile

• Degree in Biomedical Engineering, Bioengineering, Materials Engineering or a related field.
• Proficient English (minimum B2/C1 level).
• Organised, analytical and detail‑oriented with a strong desire to learn in a multidisciplinary environment.

Required skills

• SolidWorks
• CAD software
• Experience or knowledge in document management.