Biocompatibility Program Manager

Acumed LLC

Not specified (assumed hybrid based on industry norms)
Iso-10993 biocompatibility standards
Surgically invasive and implantable principles
Cytotoxicity and sensitization testing methods
Acumed LLC is seeking a Biocompatibility Program Manager to oversee compliance with biocompatibility standards for their medical products. The role involves cross-functional collaboration, project management, and training to ensure product safety and regulatory adherence

Job Summary

  • The Biocompatibility Program Manager is responsible for establishing and directing all aspects of the biocompatibility program to ensure product safety and regulatory compliance.
  • This role requires cross-functional collaboration to apply biocompatibility principles to new product development across all business units within a matrixed organization.
  • The successful candidate will manage external vendors, oversee budget planning, and present program updates to executive teams while ensuring adherence to FDA and EU-MDR regulations.

Matching Summary

Match Score: 85

Acumed LLC is seeking a Biocompatibility Program Manager to oversee compliance with biocompatibility standards for their medical products. The role involves cross-functional collaboration, project management, and training to ensure product safety and regulatory adherence.

Skills & Requirements

Must-have

  • ISO-10993 biocompatibility standards
  • Surgically invasive and implantable principles
  • Cytotoxicity and sensitization testing methods
  • Project management for biocomp initiatives
  • Vendor and consultant management

Nice-to-have

  • Advanced education in toxicology or microbiology
  • Strong technical writing and communication skills
  • Experience with statistical models for test data
  • Matrixed organization leadership experience

Key Requirements

  • Bachelor's degree in biological or physical sciences or engineering
  • Minimum 5 years of experience applying biocompatibility principles
  • Proficiency in ISO-10993, ISO-14971, FDA and EU-MDR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter