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.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.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 regulatory authorities are required.Review and approve regulatory aspects of commercial mater
📌 Regulatory Affairs Specialist (Barcelona)
🏢 Rob Surgical
📍 Barcelona
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