Senior Biocompatibility Scientist: Regulatory & Risk Expert

Physiol in the United States seeks a Biocompatibility Specialist to lead retrospective gap assessments and develop BEPs in line with ISO 10993-1 and FDA guidance. You will compile safety evidence across legacy products and coordinate with testing labs to ensure GLP-compliant study design.

This role involves authoring BERs, TRAs, and material reports for regulatory submissions (510(k), PMA, De Novo, CE MDR), guiding risk-based testing strategies, and supporting post-market activities and audits