- A comprehensive understanding of ISO standards and Notified Body expectations is essential.
- Bachelor's degree in a relevant field such as chemistry or biology;
- Multidisciplinary experience working with polymer-based implants or dental implants;
- Familiarity with Notified Bodies' regulatory requirements;
- Strong analytical skills and attention to detail;
expert toxicology advisor - asti - beBeeBiocompatibility
Titolo del lavoro: Biocompatibility & Toxicology Consultant (BEP Review | EU MDR | Dermal Fillers)
Descrizione
Senior Biocompatibility Specialist
Glyance is seeking an experienced professional to provide expert review and analysis of biological evaluation plans for dermal filler products, ensuring compliance with EU MDR regulations.
The ideal candidate will have hands-on experience in toxicology strategy development, including assessment of degradation products, residual cross-linkers, impurities, and exposure routes. Prior direct interaction with Notified Bodies on biocompatibility topics under EU MDR is highly desirable.
Key Requirements
This consultancy engagement will be conducted on an hourly basis. The consultant will work independently to identify gaps, risks or over-testing within existing BEPs. They must align the plan according to EU MDR