Glyanceis 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
AlignmentwithEU 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)
Dermalfillers(ideal) b) Long-term implantable orinjectable 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. Priordirectinteraction with Notified Bodies on biocompatibility/ toxicologytopicsunderEU MDR(MDD-only experience is insufficient) Hands-on ownership of toxicology strategy (not academic review only)including assessment ofdegradation 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 orsimilar products,we’dbe happy to connect. To keep this efficient andaligned onscope,we’reusingavery shorttechnical formto confirm relevant MDR experience, availability, and hourly rate before scheduling a call. If this fits your background and interest,here’sthe link:https://forms.office.com/r/vBSsWiXWqD Once reviewed,we’llmove directly toa short discussion.
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Dermalfillers(ideal) b) Long-term implantable orinjectable 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. Priordirectinteraction with Notified Bodies on biocompatibility/ toxicologytopicsunderEU MDR(MDD-only experience is insufficient) Hands-on ownership of toxicology strategy (not academic review only)including assessment ofdegradation 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 orsimilar products,we’dbe happy to connect. To keep this efficient andaligned onscope,we’reusingavery shorttechnical formto confirm relevant MDR experience, availability, and hourly rate before scheduling a call. If this fits your background and interest,here’sthe link:https://forms.office.com/r/vBSsWiXWqD Once reviewed,we’llmove directly toa short discussion.
#J-18808-Ljbffr