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hace 2 semanas
At iVascular, we are dedicated to the design, manufacturing, production, and commercialization of medical devices for the treatment of cardio, neuro, and endovascular diseases and to become a reference in the vascular field by enhancing the value of technology and innovation.Todas las habilidades, cualificaciones y experiencia relevantes que necesitará un candidato seleccionado se enumeran en la siguiente descripción.We are a national company founded in 2010 in Barcelona (Spain) in a phase of growth and international expansion, with subsidiaries already established in Europe, Latin America, Canada, and China, and a team of more than 550 employees covering the entire manufacturing process through vertical integration.We are currently seeking a passionate and experienced Head of Clinical Evaluation to join our Clinical team at our site in Sant Vicenç dels Horts (Barcelona).You will be responsible for leading the Clinical Evaluation unit, driving the company's clinical strategy. You will oversee the development, writing and supervision of all key clinical documentation, ensuring high-quality systematic literature reviews and the preparation, review and approval of Clinical Evaluation Reports, always in full compliance with the European Medical Device Regulation.KEY RESPONSIBILITIES:Lead the Clinical Evaluation unit, managing the team and ensuring alignment with the company's overall clinical strategy.Oversee and execute comprehensive systematic literature reviews, ensuring robust methodology, full traceability and the appropriate use of specialized databases.Critically appraise all available clinical evidence—both internal data and published literature—to support well-founded conclusions on device safety and performance.Direct and contribute to the development, writing, validation and approval of Literature Search Reports and Clinical Evaluation Reports (CERs).Prepare key clinical documentation, including Literature Search Reports, Clinical Evaluation Reports, PMCF Reports and SSCPs.DESIRED PROFILE:Medical degree (MD) is required, preferably (valuable) with specialization in cardiovascular, neurovascular or peripheral vascular medicine.High level of English and Spanish.10 years of experience with EU MDR 2017/745, including extensive authorship, review and approval of CERs and clinical documentation.Strong experience authoring PMCF Reports, SSCPs, Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER).Valuable experience with ISO 14155 and other clinical investigation standards.Strong expertise writing, literature appraisal and systematic literature searches.Familiarity with reference management tools (Zotero, Mendeley, etc.).WHAT WE OFFER:Permanent and stable contract in a project with high global impact and expanding internationally.Professional and personal development in a vibrant, dynamic, and youthful environment.Competitive salary tailored to your experience, along with an attractive benefits package.Flexible working hours to support a healthy work-life balance.Flexible compensation (meal vouchers, transportation, and childcare assistance).Access to our iWellness program: gym and physiotherapist on site.Corporate events and gifts. xohynlm Subsidized on-site company cafeteria.
