Descripción de la oferta
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.La siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto.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 materials, including brochures and website content.Promote a strong quality culture focused on compliance and continuous improvement.What are we looking for?Bachelor's degree in Health Sciences, Biomedical Engineering, Pharmacy, Biology, Chemistry, Engineering or another relevant scientific discipline.At least 6 years of experience in Regulatory Affairs within the Medical Device industry.Experience preparing Technical Documentation for medical devices.Knowledge of European Medical Device Regulation (MDR 2017/745).Experience interacting with Notified Bodies and Competent Authorities is highly valued.Experience with FDA regulatory pathways (510(k), De Novo) is considered a strong advantage.Previous experience in the surgical robotics industry will be considered a strong asset.Strong understanding of medical device regulations, standards and regulatory guidance.Knowledge of MDR 2017/745, RD 192/2023 and relevant standards such as ISO 13485, ISO 14971, ISO 14155, ISO 10993, ISO 11607, ISO 11135, IEC 60601 and related MDCG/FDA guidance documents.Excellent analytical and problem-solving skills.Strong attention to detail and documentation skills.Ability to interpret complex regulations and translate them into practical actions.Proactive, organized and collaborative mindset.Excellent communication and stakeholder management skills.Professional proficiency in English.Fluent Spanish (written and spoken).Advanced Microsoft Office skills and experience working with ERP systems.What do we offer?Competitive salary aligned with experience.Highly innovative environment with real impact on patients' lives.Opportunity to work on cutting‑edge surgical robotic systems in an international and multidisciplinary team. xcskxlj Continuous learning and professional development in one of the fastest-growing sectors in MedTech.#J-18808-Ljbffr
