Senior Attorney, Legal

## At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.## Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference.

Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.## ##

Position Summary:

The Senior Attorney, Legal (Regulatory and Quality Counsel) will provide specialized legal support within Illumina’s global regulatory legal practice, advising on regulatory and quality matters affecting the full lifecycle of Illumina’s medical device, diagnostics, and research use only (RUO) products.

This role partners closely with Regulatory Affairs, Quality, Medical Affairs, Global Compliance, and Commercial functions to deliver clear, business-focused legal advice that ensures compliance with U.S. Food and Drug Administration (FDA) and international regulatory requirements. The Senior Attorney will play a key role in interpreting and applying complex regulatory frameworks to support product development, labeling, marketing, and post-market activities in a dynamic, highly matrixed global organization.##

Essential Duties and Responsibilities:

* 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.
* Conduct legal research and analysis on evolving global regulatory trends and emerging requirements.
* Assist with preparation of internal policies, procedures, and training to support regulatory compliance and inspection readiness.
* Draft and review correspondence and documentation for regulatory submissions and responses.
* Coordinate with Commercial Legal, Compliance, and Corporate Development teams on matters involving regulatory considerations.
* Engage with external counsel as needed to support specialized regulatory matters in foreign jurisdictions.
** Key

Competencies:

**
* ** Regulatory Law Expertise:
** Demonstrated understanding of the FDCA, FDA medical device regulations, and comparable international frameworks (e.g., IVDR, ISO 13485).
* ** Analytical Judgment:
** Ability to identify and assess regulatory risks and provide pragmatic, business-aligned legal solutions.
* *
* Cross-Functional Collaboration:

** Works effectively across regulatory, quality, and commercial teams in a complex matrixed organization.
* ** Business Acumen:
** Understands the interplay between legal advice and business objectives in a scientific, innovation-driven environment.
* ** Communication:
** Delivers clear, concise legal guidance to technical and non-legal stakeholders.
* ** Adaptability:
** Operates effectively in a fast-paced and evolving global regulatory landscape.
*
* Supervisory Responsibilities:

** This is an individual contributor role. The Senior Attorney may provide guidance or informal mentorship to junior attorneys or legal staff but does not have formal direct reports.
*
* Minimum Qualifications:

*** Juris Doctor (JD) from an accredited law school.
* Licensed to practice law in at least one U.S. jurisdiction.
* Typically requires 10–12 years of legal practice, including 6–8 years of in-house or directly relevant experience in the medical device, diagnostics, or biotechnology industry, or an equivalent combination of education and…