Sr. Compliance Manager

Abbott

Sylmar, CA, United States
Base: $148,700.00 – $297,300.00; bonus/equity: not...
Onsite
8 years quality systems experience
In vitro diagnostics manufacturing knowledge
Fda cfr 820 and iso 13485 expertise
This onsite role sets strategy for internal, clinical, and external audits ensuring sites are audit ready at all times while managing a team of auditors across multiple sites

Job Summary

  • This onsite role sets strategy for internal, clinical, and external audits ensuring sites are audit ready at all times while managing a team of auditors across multiple sites.
  • The position serves as the main external regulatory body interface for the US, directing inspection strategies and acting as a Subject Matter Expert for audits and assessments.
  • Employees qualify for free medical coverage in the Health Investment Plan, an excellent retirement savings plan with high employer contribution, and tuition reimbursement benefits.

Matching Summary

This onsite role sets strategy for internal, clinical, and external audits ensuring sites are audit ready at all times while managing a team of auditors across multiple sites.

Salary

Base: $148,700.00 – $297,300.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • 8 years Quality Systems experience
  • In Vitro Diagnostics manufacturing knowledge
  • FDA CFR 820 and ISO 13485 expertise
  • Team management of auditors
  • Global audit strategy development

Nice-to-have

  • Experience with Notified Body Audit Coordination Committee
  • Knowledge of MDD regulations
  • Strategic advocacy forum participation
  • Risk prioritization and mitigation skills
  • Cross-functional leadership capabilities

Key Requirements

  • Bachelor's degree required
  • Minimum 8 years in Quality/Regulatory Compliance
  • 5 years in a management capacity
  • Experience in In Vitro Diagnostics or medical device manufacturing
  • Knowledge of ISO 14971 and CFR 803/806/820

Work Rights

Not specified

Tailored Resume

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