Biocompatibility & Toxicology Consultant (Bep Review | Eu Mdr | Dermal Fillers)
2 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-testing- Alignment with EU MDR and Notified Body expectations-Practical recommendations to strengthen CE readiness- Support during Notified Body review, including responses to questions and deficienciesHighly relevant experience includes:- Experience witha) 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 consultant- Hourly, 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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Lazio, Italia Hellosmile A tempo pienoOverviewGlyanceis 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...
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Lazio, 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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Lazio, 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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Lazio, 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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Lazio, 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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