Biologe (m/w/d)
Core
Leading the Biological Affairs team to plan, steer, and ensure quality of biological evaluations for medical devices throughout their lifecycle, assessing biological risks, and deriving appropriate measures.
Role type
Team Leader, Biological Affairs (Medical Devices)
Builds
Medical device endoprostheses
Domain
Medical technology / Biocompatibility / Regulatory Affairs
Required skills
Biological risk assessment, Lifecycle management, Regulatory compliance (MDR, ISO 10993), Team leadership, Process development, Audit support, Cross-functional project management
Preferred skills
Experience in Medical Device development and approval, Knowledge of FDA regulations, Experience with interdisciplinary teams
Technologies
MS-Office
Responsibilities
Lead and develop the Biological Affairs team, Plan and control biological evaluations of medical devices, Evaluate biological risks and define mitigation measures, Develop processes and standards in Biological Affairs, Participate in cross-functional projects and support audits/inspections
Seniority
Senior, hands-on IC with leadership responsibilities