Director Global Biocompatibility and Toxicology Competence Center (m/w/d)
Core
Establish and lead a global biocompatibility and toxicology competence center to define and implement safety strategies for medical devices and drug packaging materials.
Role type
Director, Global Biocompatibility and Toxicology Competence Center
Builds
Global biocompatibility strategy, SOP packages, and qualification of test laboratories for medical devices and primary packaging.
Domain
Healthcare / Medical Devices / Regulatory Quality
Required skills
Biocompatibility evaluation, Toxicology, Risk management, Laboratory management, Strategic planning, Project management
Preferred skills
Knowledge of ISO 10993 series, PTC Windchill PDM, Polarion ALM, German/French/Italian languages
Technologies
ISO 10993 series, PTC Windchill, Polarion ALM, Microsoft Office
Responsibilities
Build and lead the Global Biocompatibility and Toxicology Competence Center; Derive overarching biocompatibility strategy for medical devices and drug packaging; Process-owner for biocompatibility SOP package; Qualify test laboratories and align study requirements; Oversee creation of biocomp files (BEP, BER, TRA); Manage interfaces with R&D teams and regulatory agencies.
Seniority
Director, Strategic Leadership