Descripción de la oferta
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.
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 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
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 3 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
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.
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