Senior Attorney, Legal

The estimated base salary range for the Senior Attorney, Legal role based in the United States of America is: $187,400 - $281,000.

We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics.

Prior in-house counsel experience in medical device, med tech, or life sciences organizations.

Familiarity with FDA Quality System Regulation (QSR), ISO 13485, and international regulatory requirements.

Law firm experience supporting regulatory clients preferred.

Provide legal guidance on U.S.

and international medical device, diagnostic, and life science regulatory requirements, including the FDCA, FDA regulations, and the EU In Vitro Diagnostic Regulation (IVDR).

Partner with Regulatory Affairs and Quality to support product submissions, market access strategies, and post-market regulatory obligations.

Review and advise on product labeling, promotional materials, and communications to ensure regulatory compliance and mitigate risk.

Support inspection readiness and regulatory audits, including responses to inquiries from the FDA and other global regulatory authorities.

Collaborate cross-functionally to assess regulatory risks in contracts, quality agreements, and business transactions.