Director, Quality Assurance - Regulatory

Labcorp

Base: $130,000 - $150,000 annually; bonus: eligibl...
Not specified
15+ years experience in diagnostics or medical devices
3+ years direct compliance under 21 cfr 820
Expertise in iso 13485 regulatory frameworks
Labcorp is seeking a Director of Quality Assurance - Regulatory to lead quality governance for an enterprise-wide specimen collection kit program. This role requires extensive experience in diagnostics and regulatory compliance, specifically in FDA medical device regulations and ISO 13485

Job Summary

  • This role provides strategic and operational quality leadership for an enterprise-wide specimen collection kit program aligned with Labcorp's mission to improve health.
  • The Director will be accountable for the design, implementation, and governance of a compliant quality management system supporting the lifecycle of diagnostic kits across all functional areas.
  • Employees are eligible for comprehensive benefits including medical, dental, vision, life insurance, 401(k), paid time off, and tuition reimbursement.

Matching Summary

Match Score: 85

Labcorp is seeking a Director of Quality Assurance - Regulatory to lead quality governance for an enterprise-wide specimen collection kit program. This role requires extensive experience in diagnostics and regulatory compliance, specifically in FDA medical device regulations and ISO 13485.

Salary

Base: $130,000 - $150,000 annually; Bonus: Eligible for annual bonus based on corporate and segment performance; Benefits: Comprehensive medical, dental, vision, 401(k), PTO, and stock purchase plan

Skills & Requirements

Must-have

  • 15+ years experience in diagnostics or medical devices
  • 3+ years direct compliance under 21 CFR 820
  • Expertise in ISO 13485 regulatory frameworks
  • Design and implementation of Quality Management Systems
  • Oversight of CAPA, risk management, and supplier quality

Nice-to-have

  • Familiarity with laboratory developed tests and CAP/CLIA
  • Experience supporting FDA inspections and audits
  • Strong ability to influence cross-functional teams
  • Proven track record in continuous improvement culture
  • Excellent communication skills for complex concepts

Key Requirements

  • Bachelor's degree in biology, chemistry, engineering, or related field
  • 15+ years experience in operations, quality, or regulatory within diagnostics
  • 3+ years direct experience in compliance activities under 21 CFR 820 or ISO 13485

Work Rights

Not specified

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