Expertise in eu in vitro diagnostic regulation (ivdr)
Hands-on in-house legal experience in med tech
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 legal strategy for product development, commercialization, and post-market obligations while collaborating across Regulatory Affairs, Quality, and Sales teams.
Illumina offers a competitive base salary range of $224,900 to $337,300 along with variable cash programs, equity, and comprehensive health benefits.
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, genomics sequencing access
Skills & Requirements
Must-have
Deep knowledge of FDCA and FDA regulations
Expertise in EU In Vitro Diagnostic Regulation (IVDR)
Hands-on in-house legal experience in med tech
Experience advising on global regulatory submissions
Ability to navigate matrixed global environments
Nice-to-have
Familiarity with ISO 13485 international norms
Law firm experience preferred but not required
Strong background in business development collaborations
Experience with post-market vigilance strategies
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 medical device or biotechnology