Senior Manager Biocompatibility
Core
Leads a team of biocompatibility specialists to deliver biological evaluations for medical devices in line with ISO 10993 standards, supporting New Product Development and Lifecycle Management projects.
Role type
Senior Manager, Biocompatibility
Builds
Biological evaluations and testing data for medical devices (Ostomy, Infusion, Wound, Continence Care)
Domain
Medical Device / Biocompatibility / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biocompatibility assessments, ISO 10993 standards, FDA submission management, toxicology principles, extractable and leachable chemical characterization, biological evaluation protocols, resource allocation, team coaching, cross-functional collaboration
Preferred skills
Advanced degree in Biomedical Engineering, Bioengineering, Biology, Biochemistry, Microbiology, or Toxicology
Technologies
ISO 10993, FDA regulatory frameworks
Responsibilities
Manage and develop the biocompatibility team; Allocate resources in line with project needs; Ensure seamless collaboration with project, regulatory, and clinical teams; Lead accurate project planning and timely execution of biocompatibility activities; Evaluate and execute biocompatibility studies; Analyze and interpret biocompatibility testing results; Support biological hazards risk analysis activities.
Seniority
Senior, hands-on IC with team leadership
