Lavori attuali relativi a Biocompatibility & Toxicology Consultant (BEP Review | EU MDR | Dermal Fillers) - Catania - Glyance
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Senior Clinical Research Associate
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Biocompatibility & Toxicology Consultant (BEP Review | EU MDR | Dermal Fillers)
28 minuti 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 10993) 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 deficiencies Highly 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 routes Engagement type: External consultant Hourly, flexible, execution-focused If you have practical MDR experience and have supported CE submissions for fillers or similar products, we’d be happy to connect.
