Biocompatibility & Toxicology Consultant (BEP Review | EU MDR | Dermal Fillers)
14 minuti fa
OverviewGlyanceis seeking a senior Biocompatibility & Toxicology Consultant to provide an independent, critical review of an existing Biological Evaluation Plan (BEP) for dermal filler products, as part of an active CE submission under EU MDR.This is a consulting engagement (hourly / project-based)—not an employment role.Scope of supportIndependent review of an existing BEP (ISO 10993)Identification of gaps, risks, or over-testingAlignment with EU MDR and Notified Body expectationsPractical recommendations to strengthen CE readinessSupport during Notified Body review, including responses to questions and deficienciesExperience / QualificationsExperience with a) Dermal fillers (ideal) b) Long-term implantable or injectable medical devices (strong preference) c) Experience with polymer-based implants, dental implants, or resorbable membranes (also relevant).Experience reviewing or challenging third-party BEPs is a strong advantage.Prior direct interaction with Notified Bodies on biocompatibility/ toxicology topics under EU MDR (MDD-only experience is insufficient)Hands-on ownership of toxicology strategy (not academic review only) including assessment of degradation products, residual cross-linkers, impurities, and exposure routesEngagement typeExternal consultantHourly, flexible, execution-focusedIf you have practical MDR experience and have supported CE submissions for fillers or similar products, we’d be happy to connect.#J-18808-Ljbffr
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Rome, Italia Glyance A tempo pienoGlyance is seeking a senior Biocompatibility & Toxicology Consultant to provide an independent, critical review of an existing Biological Evaluation Plan (BEP) for dermal filler products, as part of an active CE submission under EU MDR.This is a consulting engagement (hourly / project-based) — not an employment role.Scope of support includes:- Independent...
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EU MDR Biocompatibility
14 minuti fa
Rome, Italia HelloSmile A tempo pienoA consulting firm in Italy is seeking a senior Biocompatibility & Toxicology Consultant to conduct a critical review of a Biological Evaluation Plan (BEP) for dermal filler products. This is a flexible, hourly-based consulting role aimed at ensuring CE readiness under EU MDR regulations. Ideal candidates will have hands-on biocompatibility experience and...
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Rome, Italia Altro A tempo pienoOverviewThe Senior Consultant will work closely with the Partner and the Director of the relevant practice of the firm. In particular, they will manage projects of advocacy, lobbying and coalition building. The Senior Consultant is required to monitor the legislative, regulatory and policy activity of the main Italian government bodies and regulatory...
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Rome, Italia Nexia Audirevi A tempo pienoFondata nel 1983 come società indipendente di Revisione e Organizzazione Contabile e iscritta all’ex Albo Speciale Consob nel 1997, oggi abrogato, e nel Registro dei Revisori Contabili con Decreto Ministeriale del 17 luglio 2000, Audirevi è una realtà multifunzionale che affianca le imprese nelle attività di Audit & Assurance , Transaction & Advisory ,...
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6 giorni fa
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