Biocompatibility & Toxicology Consultant (Bep Review | Eu Mdr | Dermal Fillers)

9 ore fa

Lecce, Italia Glyance A tempo pieno

Glyance 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 review of an existing BEP (ISO *****)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 deficienciesHighly relevant experience includes:Experience 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 type:External 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.

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