The Director will serve as a senior legal advisor ensuring compliance with U.S. FDA and EU IVDR regulations for medical devices and diagnostics
Job Summary
The Director will serve as a senior legal advisor ensuring compliance with U.S. FDA and EU IVDR regulations for medical devices and diagnostics.
This role requires leading a team of legal professionals while collaborating across Regulatory Affairs, Quality, and Sales to mitigate global regulatory risks.
Illumina offers a competitive base salary range of $224,900 - $337,300 along with variable cash programs, equity, and comprehensive benefits including health coverage.
Matching Summary
The Director will serve as a senior legal advisor ensuring compliance with U.S. FDA and EU IVDR regulations for medical devices and diagnostics.
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 IVDR framework
In-house counsel experience in med tech
10+ years management experience required
JD from accredited law school
Nice-to-have
Experience with ISO 13485 standards
Familiarity with QSR regulations
Law firm experience preferred
Matrixed multinational environment experience
Strategic collaboration skills
Key Requirements
Juris Doctor (JD) degree
Licensed to practice in at least one US jurisdiction