Senior Biocompatibility Scientist

Senior Biocompatibility Scientist responsible for defining and executing a biological safety strategy across the product life cycle, including planning biocompatibility evaluations (ISO 10993), generating evidence for regulatory submissions, and maintaining market access. Key duties include serving as SME for biocompatibility and microbiology activities, advising on materials selection and testing strategies, interpreting ISO/FDA/MDR/AAMI regulatory requirements, maintaining documentation, coordinating with external labs and contract testing services, vendor management, due diligence of test labs, leading cross-functional project teams for biocompatibility and microbiology testing, conducting risk-based change assessments, supporting external audits by Notified Bodies and regulators, educating colleagues on biological safety evaluations, and engaging regulators on related matters. Essential skills include knowledge of FDA/USP/MDR/AAMI/ISO standards (ISO 10993, ISO 18562), microbiology and analytical chemistry, supplier/audit experience, strong organization and communication, ISO 13485, MDR, and FDA QMS familiarity, and proficiency with MS Office and statistical tools (e.g., Minitab). Additional focus on risk assessment methodologies in product development and collaboration to ensure device safety and efficacy.