P At strong LVDBiotech /strong(iVascular), we are dedicated to the design, manufacturing, production, and commercialization of medical devices for the treatment of strong cardio /strong, strong neuro /strong, and strong endovascular /strong diseases and to become a reference in the vascular field by enhancing the value of technology and innovation. /p p 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. /p p We are currently seeking a passionate and experienced bem Senior /em em Clinical Evaluation Specialist /em /b to join our bem Clinical /em /b team at our site in b Sant Vicenç dels Horts /b (Barcelona). /p p You will be responsible for the development a creation of Clinical Documents in accordance the European Medical Device Regulation conducting literature reviews and writing Clinical Evaluation Reports. /p pstrong KEY RESPONSIBILITIES: /strong /pulli Development, writing and validation of Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs). /lili Execute comprehensive strong systematic literature reviews /strong, ensuring robust methodology, full traceability and appropriate use of specialized scientific databases. /lili Prepare Literature Seach Reports. /lilistrong Critically appraise clinical evidence /strong (manufacturer-held data and published literature) to support conclusions on device strong safety and performance /strong in accordance with EU MDR. /li /ul pu Review and prepare key clinical MDR documentation, including: /u /p ulli CDP (clinical development plan). /lili PMCF-plan (post market clinical follow-plan) /lili PMCF Reports. /lili SSCPs (Sammery of safety and clinical performance). /li /ul pstrong u Develop, write and update /u /strongu key clinical documentation, including: /u /p ulli Literature Search Reports. /lilistrong Clinical Evaluation Reports. /strong /lilistrong Clinical Evaluation Plans (CEP). /strong /lilistrong PMCF Plans and PMCF Reports. /strong /lilistrong SSCPs. /strong /li /ul ulli Support the strong clinical evaluation strategy /strong across the medical device portfolio, in close collaboration with Regulatory Affairs and Quality teams. /lili Contribute to strong Post-Market Surveillance (PMS) /strong activities, including PSURs and PMCF-related documentation. /lili Interact with strong Notified Bodies and Competent Authorities /strong in relation to clinical documentation and regulatory queries. /lili Ensure all clinical documentation complies with strong EU MDR 2017/745 /strong, MEDDEV guidance and applicable MDCG documents. /li /ul pstrong DESIRED PROFILE: /strong /pullistrong Scientific or medical background /strong (Biomedical Sciences, Life Sciences, Biotechnology, Pharmacy or similar). /lilistrong Minimum of 6 years of hands-on experience in Clinical Evaluation of medical devices /strong under strong EU MDR 2017/745 /strong. /lili Proven hands-on experience authoring and updating: /lilistrong CERs /strong /lilistrong CEPs /strong /lilistrong PMCF Plans Reports /strong /lilistrong SSCPs /strong /li /ul ulliu Solid understanding of: /u /lilistrong MEDDEV 2.7/1 Rev.4 /strong /lilistrong MDCG guidance /strong /lili Post-market clinical requirements. /li /ul ulli Experience interacting with b Notified Bodies /b regarding clinical documentation is highly valued. /lili Strong expertise in b scientific writing, literature appraisal and systematic literature searches /b. /lili Familiarity with b reference management tools /b (Zotero, Mendeley or similar). /lilib Fluent English and u Spanish /u /b(written and spoken). /li /ul pstrong WHAT WE OFFER: /strong /pulli Permanent and stable contract in a project with high global impact and expanding internationally. /lili Professional and personal development in a vibrant, dynamic, and youthful environment. /lili Competitive salary tailored to your experience, along with an attractive benefits package. /lilistrong Hybrid working model with telework days, and flexible hours. From Monday to Thursday, start between 7:00 and 9:00 a.m. and finish from 4:30 p.m. onwards. On Fridays, enjoy an intensive schedule from 8:00 a.m. to 2:00 p.m. /strong /lili Flexible compensation (meal vouchers, transportation, and childcare assistance). /lili Access to our iWellness program: gym and physiotherapist on site. /lili Corporate events and gifts. /lili Subsidized on-site company cafeteria. /li /ul