At LVDBiotech (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.
Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación.
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 Senior Clinical Evaluation Specialist to join our Clinical team at our site in Sant Vicenç dels Horts (Barcelona).
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.
KEY RESPONSIBILITIES:
* Development, writing and validation of Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs).
* Execute comprehensive systematic literature reviews, ensuring robust methodology, full traceability and appropriate use of specialized scientific databases.
* Prepare Literature Seach Reports.
* Critically appraise clinical evidence (manufacturer-held data and published literature) to support conclusions on device safety and performance in accordance with EU MDR.
Review and prepare key clinical MDR documentation, including:
* CDP (clinical development plan).
* PMCF-plan (post market clinical follow-plan)
* PMCF Reports.
* SSCPs (Sammery of safety and clinical performance).
Develop, write and update key clinical documentation, including:
* Literature Search Reports.
* Clinical Evaluation Reports.
* Clinical Evaluation Plans (CEP).
* PMCF Plans and PMCF Reports.
* SSCPs.
* Support the clinical evaluation strategy across the medical device portfolio, in close collaboration with Regulatory Affairs and Quality teams.
* Contribute to Post-Market Surveillance (PMS) activities, including PSURs and PMCF-related documentation.
* Interact with Notified Bodies and Competent Authorities in relation to clinical documentation and regulatory queries.
* Ensure all clinical documentation complies with EU MDR 2017/745, MEDDEV guidance and applicable MDCG documents.
DESIRED PROFILE:
* Scientific or medical background (Biomedical Sciences, Life Sciences, Biotechnology, Pharmacy or similar).
* Minimum of 6 years of hands-on experience in Clinical Evaluation of medical devices under EU MDR 2017/745.
* Proven hands-on experience authoring and updating:
* CERs
* CEPs
* PMCF Plans & Reports
* SSCPs
* Solid understanding of:
* MEDDEV 2.7/1 Rev.4
* MDCG guidance
* Post-market clinical requirements.
* Experience interacting with Notified Bodies regarding clinical documentation is highly valued.
* Strong expertise in scientific writing, literature appraisal and systematic literature searches.
* Familiarity with reference management tools (Zotero, Mendeley or similar).
* Fluent English and Spanish (written and spoken).
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.
* 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.
* Flexible compensation (meal vouchers, transportation, and childcare assistance).
* Access to our iWellness program: gym and physiotherapist on site.
* Corporate events and gifts. xpzdshu
* Subsidized on-site company cafeteria.