Descripción de la oferta
About us We are a healthtech company specialized in the development of advanced robotic surgery systems for high-precision minimally invasive procedures. Founded in 2012 as a spin-off from UPC and IBEC, our mission is to make robot-assisted surgery more accessible, precise, and efficient worldwide. We design and develop next-generation computer-controlled surgical robotic systems and endoscopic instruments.Por favor, asegúrese de leer completamente el resumen y los requisitos de esta oportunidad de empleo que se detallan a continuación.Your mission As a Medical Affairs Specialist, you will support the generation, management and communication of clinical and scientific evidence for our medical robotic systems. You will work closely with clinical, regulatory and R&D team to ensure strong scientific support across the product lifecycle. Your main responsibilities Support the definition of pre-clinical and clinical strategies for design and development projects Prepare supporting documentation for discussions with Medical Advisory Boards and pre-clinical and clinical service providers (CROs). Conduct literature searches, selection, and critical appraisal relevant to design and development projects. Identify, evaluate, and screen potential partners (e.g., CROs, external laboratories) to support clinical activities. Coordinate clinical investigations and related activities. Support the training of clinical staff during the execution of usability studies. Prepare and maintain up-to-date protocols and reports in accordance with established timelines for activities including biocompatibility studies, Post-Market Surveillance (PMS) plans, Post-Market Clinical Follow-up (PMCF) plans, and related strategies, ensuring compliance with MDR (EU) 2017/745. Support supplier evaluation, selection, monitoring, and re-evaluation processes. Ensure compliance with Quality Management System (QMS) requirements. Support the preparation of Technical Documentation and other design and development files.What are we looking for? Degree in Biomedical Engineering, Medicine, Nursing, Biology, Biotechnology or related fields Strong understanding of human anatomy and physiology Experience as a Pre-Clinical and Clinical Research Manager in medical device development projects, preferably resulting in successful CE certification. Experience in Medical Affairs, Clinical Research, Surgical Robotics and/or Medical Devices Knowledge of minimally invasive surgery or surgical environments is highly valuedSkills required Ability to prepare records, protocols, and reports that demonstrate activities have been carried out appropriately and in compliance with applicable requirements. Strong organizational and planning skills. Problem-solving mindset and analytical thinking. Excellent communication skills. Strong teamwork and collaboration skills. Professional proficiency in English. Fluent Spanish (written and spoken). xcskxlj What do we offer? Full-time permanent contract Competitive salary aligned with experience Flexible working hours Highly innovative environment with real impact on patients’ lives Strong engineering culture inside a medical robotics company developing surgical systems
