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Physiol

3 jobs near Columbus, OH

Physiol

Senior Biocompatibility Scientist

Waltham, MA · On-site

$120 - $170/hr

* Conduct retrospective biocompatibility gap assessments across legacy product families, generating or compiling documentation to establish a comprehensive baseline of biological safety evidence

Physiol

WI · On-site

$70 - $90/hr

European Field Service Engineer Full details of the job. Key Responsibilities * Perform scheduled preventative maintenance and emergency service calls in line with contract requirements * Repair ...

Physiol

$120 - $170/hr

* Conduct retrospective biocompatibility gap assessments across legacy product families, generating or compiling documentation to establish a comprehensive baseline of biological safety evidence

Senior Biocompatibility Scientist

Physiol

Waltham, MA • On-site

$120 - $170/hr

Other

Posted 4 days ago

Job description

  • Conduct retrospective biocompatibility gap assessments across legacy product families, generating or compiling documentation to establish a comprehensive baseline of biological safety evidence
  • Support sustaining and change management activities by providing strategic assessment of biological safety impact in accordance with ISO 10993-1
  • Develop and execute biocompatibility evaluation plans (BEPs) for new product development initiatives in accordance with ISO 10993-1 and FDA guidance, aligned to device classification, contact type, and contact duration
  • Author and review biological evaluation reports (BERs), toxicological risk assessments (TRAs), and material characterization reports supporting 510(k), PMA, De Novo, and international submissions (CE marking under MDR, etc.)
  • Manage biocompatibility testing programs with contract testing laboratories, ensuring GLP compliance and scientifically sound study design
  • Apply risk-based approaches to minimize redundant testing, leveraging existing data where scientifically justified
  • Support post-market and complaint driven biological safety assessments
  • Serve as biocompatibility subject matter expert during FDA/notified body interactions, audits, and responses to regulatory questions or deficiency letters
  • Develop and maintain SOPs, templates, and standardized workflows for biocompatibility evaluations to improve consistency, efficiency, and audit-readiness across the organization
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