Principal I, Microbiology & Toxicology
Core
Scientific leader responsible for biological safety evaluation, risk-based biocompatibility strategies, and toxicological risk assessments for medical devices and combination products.
Role type
Principal I, Medical Device Toxicologist
Builds
Medical device safety conclusions and global regulatory positions
Domain
Medical Devices / Biocompatibility / Toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device toxicology expertise, ISO 10993 standards application, toxicological risk assessment, weight-of-evidence methods, regulatory submission authoring, external laboratory oversight, strategic problem solving
Preferred skills
MS or PhD in Toxicology, pharmaceutical/medical device development experience, computational toxicology knowledge, REACH/EU MDR/Proposition 65 regulations, statistics proficiency
Technologies
Computational toxicology tools, Microsoft Office suite
Responsibilities
Lead development of risk-based biological evaluation strategies, author and review Biological Evaluation Plans and Reports, integrate extractables/leachables data with toxicological hazard data, develop health-based exposure limits, serve as subject matter expert on product development and regulatory teams, lead biocompatibility workstreams and project plans, contribute to global regulatory submissions
Seniority
Principal, scientific leadership & strategy
