Biocompatibility Program Manager

Acumed LLC

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Biocompatibility program management
Iso-10993 and iso-14971 regulations
Fda and eu-mdr compliance
** Acumed LLC is seeking a Biocompatibility Program Manager responsible for overseeing the biocompatibility program to ensure compliance with safety standards for medical devices. The ideal candidate will have extensive experience in biocompatibility principles, project management, and cross-functional collaboration. **

Job Summary

  • The Biocompatibility Program Manager is responsible for establishing and directing all aspects of the biocompatibility program to ensure safe use of products in patients.
  • This role requires working cross-functionally within a matrixed environment to apply biocomp principles to new product development across all business units.
  • Candidates must manage external vendors, control budgets, and present program updates to executive leadership while maintaining compliance with global standards.

Matching Summary

Match Score: 75

** Acumed LLC is seeking a Biocompatibility Program Manager responsible for overseeing the biocompatibility program to ensure compliance with safety standards for medical devices. The ideal candidate will have extensive experience in biocompatibility principles, project management, and cross-functional collaboration. **

Skills & Requirements

Must-have

  • Biocompatibility program management
  • ISO-10993 and ISO-14971 regulations
  • FDA and EU-MDR compliance
  • Cytotoxicity and sensitization testing
  • Project management tools proficiency
  • Statistical analysis of test data
  • Vendor and consultant management

Nice-to-have

  • Advanced education in toxicology
  • Experience with SAP and Windchill
  • Strong technical writing skills
  • Matrixed organization experience
  • Executive team presentation skills

Key Requirements

  • Bachelor's degree in biological or physical sciences
  • Minimum 5 years of biocompatibility experience
  • Proficiency in surgical invasive and implantable principles

Work Rights

Not specified

Tailored Resume

Cover Letter