expert dermal filler regulatory review specialist - Chieti (CH) - beBeeBiocompatibility

Titolo del lavoro: Biocompatibility & Toxicology Consultant (BEP Review | EU MDR | Dermal Fillers)

Descrizione

Senior Biocompatibility Consultant

Glyance is seeking an experienced senior biocompatibility consultant to provide a comprehensive review of existing Biological Evaluation Plans (BEP) for dermal filler products as part of an active CE submission under EU MDR.

About the Role:

This consulting engagement is hourly/project-based and does not involve employment. The scope of support includes identifying gaps, risks or over-testing; supporting Notified Body reviews including responses to questions and deficiencies; assessing degradation products, residual cross-linkers, impurities and exposure routes in toxicology strategy development.

Requirements:

• Familiarity with dermal fillers (ideal); long-term implantable or injectable medical devices (strong preference); polymer-based implants, dental implants or resorbable membranes (also relevant)

Absence of direct interaction with Notified Bodies on biocompatibility/toxicology topics under EU MDR has been ruled out by our organization.
If you have practical experience under EU MDR regulations that directly applies to this role we'd love to discuss further possibilities.