Director, Legal (regulatory And Quality Counsel)

Illumina

San Diego, California, United States
Base: $224,900 - $337,300; bonus/equity: variable ...
Hybrid
Deep knowledge of fdca and fda regulations
Expertise in eu in vitro diagnostic regulation
Hands-on experience in med tech or biotech
The Director will serve as a senior legal advisor ensuring compliance with U.S. FDA and EU IVDR regulations while enabling business objectives for genomic technology

Job Summary

  • The Director will serve as a senior legal advisor ensuring compliance with U.S. FDA and EU IVDR regulations while enabling business objectives for genomic technology.
  • This role requires deep expertise in the Food, Drug and Cosmetics Act and the ability to provide strategic counsel on complex regulatory matters impacting medical devices and diagnostics.
  • Employees are eligible for variable cash programs, equity, and a comprehensive benefits package including health/dental/vision and paid time off.

Matching Summary

The Director will serve as a senior legal advisor ensuring compliance with U.S. FDA and EU IVDR regulations while enabling business objectives for genomic technology.

Salary

Base: $224,900 - $337,300; Bonus/Equity: Variable cash program and equity eligible; Benefits: Health/dental/vision, retirement, paid time off

Skills & Requirements

Must-have

  • Deep knowledge of FDCA and FDA regulations
  • Expertise in EU In Vitro Diagnostic Regulation
  • Hands-on experience in med tech or biotech
  • Strategic legal guidance on product lifecycle
  • Experience advising Sales and Marketing teams

Nice-to-have

  • Familiarity with ISO 13485 standards
  • Law firm experience preferred
  • Ability to navigate matrixed global environments
  • Strong leadership and mentoring skills
  • Resilience in fast-paced regulated settings

Key Requirements

  • Juris Doctor (JD) from accredited law school
  • Licensed to practice law in at least one U.S. jurisdiction
  • Minimum 18 years of related experience
  • 10+ years of management experience
  • Extensive in-house counsel experience in med tech or biotech

Work Rights

Not specified

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