Director, Biocompatibility

Abbott

Santa Clara, California, United States
Base: $172,000.00 – $344,000.00; bonus/equity: not...
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Global biocompatibility strategy execution
Iso 10993 regulatory compliance expertise
Toxicological risk assessment methodologies
** Abbott is seeking a Director of Biocompatibility to lead global biocompatibility and materials safety programs for medical devices, requiring strategic leadership and expertise in regulatory compliance. The ideal candidate should possess substantial experience in toxicology and biocompatibility, particularly within the medical device sector, and demonstrate strong leadership and collaboration skills. **

Job Summary

  • The Director will provide strategic leadership and scientific direction for the global biocompatibility program supporting Abbott's medical devices and combination products.
  • This role requires ensuring compliance with ISO 10993 standards while serving as a key liaison with regulatory agencies like the FDA and notified bodies.
  • Candidates will benefit from an excellent retirement savings plan, free medical coverage options, and tuition reimbursement programs at a Fortune admired company.

Matching Summary

Match Score: 75

** Abbott is seeking a Director of Biocompatibility to lead global biocompatibility and materials safety programs for medical devices, requiring strategic leadership and expertise in regulatory compliance. The ideal candidate should possess substantial experience in toxicology and biocompatibility, particularly within the medical device sector, and demonstrate strong leadership and collaboration skills. **

Salary

Base: $172,000.00 – $344,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, high employer retirement contribution, tuition reimbursement

Skills & Requirements

Must-have

  • Global biocompatibility strategy execution
  • ISO 10993 regulatory compliance expertise
  • Toxicological risk assessment methodologies
  • Extractables and leachables analysis
  • Leadership of scientific teams across sites

Nice-to-have

  • Experience with complex combination products
  • Influence on future regulatory frameworks
  • Strong cross-functional collaboration skills
  • Ability to drive operational excellence
  • Expertise in international regulatory guidance

Key Requirements

  • Ph.D. or M.S. in Biology, Toxicology, or Materials Science
  • Minimum 12 years of relevant experience in biocompatibility
  • Minimum 5 years of leadership experience managing scientific teams
  • Proven record leading global regulatory submissions (IDE, PMA, 510k)
  • Expert knowledge of US and global biocompatibility regulations

Work Rights

Not specified

Tailored Resume

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