About this opportunity
Physiol lists this Senior Biocompatibility Scientist: Regulatory & Risk Expert opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.