Senior Medical Device Software Risk And Compliance Auditor

Abbott

Abbott Park, Illinois, United States
Base: $129,300.00 – $258,700.00; bonus/equity: not...
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Iec 62304 medical device software standard
Iso 13485 quality management system compliance
Fda 21 cfr part 11 and part 820 regulations
** Abbott is seeking a Senior Medical Device Software Risk and Compliance Auditor to ensure compliance with regulatory requirements and industry standards in software development for medical devices. This role involves conducting audits, assessing risk management, and ensuring the quality of software products across various divisions. **

Job Summary

  • This role leads in-depth risk-based Quality System audits focusing on product and non-product software across Abbott manufacturing sites.
  • The position ensures executive management is aware of compliance business risks and regulatory requirements while protecting patient safety.
  • Employees qualify for free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.

Matching Summary

Match Score: 75

** Abbott is seeking a Senior Medical Device Software Risk and Compliance Auditor to ensure compliance with regulatory requirements and industry standards in software development for medical devices. This role involves conducting audits, assessing risk management, and ensuring the quality of software products across various divisions. **

Salary

Base: $129,300.00 – $258,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • IEC 62304 medical device software standard
  • ISO 13485 quality management system compliance
  • FDA 21 CFR Part 11 and Part 820 regulations
  • GAMP 5 CSV software validation expertise
  • Risk-based audit program development
  • Software lifecycle assessment and reporting

Nice-to-have

  • Cross-divisional collaboration skills
  • Executive communication and decision making
  • Continuous improvement initiative support
  • Emerging regulatory trend monitoring
  • Professional education and training delivery

Key Requirements

  • Four-year degree in scientific, technical or compliance discipline
  • Lead auditor certificate for Quality System audits desirable
  • 10+ years in software design and development in medical device industry
  • Experience with SAMD, SIMD, and cloud-based applications
  • Strong understanding of ISO 14971 and GxP principles

Work Rights

Not specified

Tailored Resume

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