? 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. ? Your mission As a Regulatory Affairs Specialist, you will play a key role in ensuring our medical robotic systems comply with international regulatory requirements throughout the product lifecycle. You will work closely with Quality, Medical Affairs, R&D; teams to define regulatory strategies, prepare technical documentation and support the successful approval of our products in Europe, the United States and other international markets. ?️ Your main responsibilities * Define and execute regulatory strategies to support product registrations in Europe, the US and other international markets. * Prepare,



maintain and manage Technical Documentation for medical device approvals under MDR, FDA and other applicable regulatory frameworks. * Analyze regulatory requirements from authorities and Notified Bodies (e.g. MDR, FDA, AEMPS and other international agencies). * Act as the main point of contact with Notified Bodies, Competent Authorities and regulatory agencies throughout product approval processes. * Participate in regulatory audits and inspections. * Prepare and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and support Biological Evaluation Reports (BER). * Conduct literature reviews to maintain up-to-date state-of-the-art evidence. * Support vigilance and Post-Market Surveillance (PMS) activities. * Monitor regulatory changes, standards and guidance documents, performing gap analyses when required. * Assess the regulatory impact of changes to suppliers, manufacturing processes and products, determining whether submissions to regula

📌 Regulatory Affairs Specialist (Barcelona)
🏢 Rob Surgical
📍 Barcelona