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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.
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. xohynlm