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Biocompatibility & Toxicology Consultant (Bep Review | Eu Mdr | Dermal Fillers)
3 settimane fa
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 expectations-Practical 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-focused
