Senior Clinical Evaluation Specialist

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.

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.

• 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.

• 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
• SSCPs
• Solid understanding of:
• 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).

• 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.