Senior Analyst Regulatory Compliance (San Diego / Hybrid)

Regulatory Compliance Senior Analyst

The Regulatory Compliance Senior Analyst supports Illumina's global compliance framework through the execution and continuous improvement of compliance auditing and monitoring activities. This role ensures that Illumina's operations, quality systems, and regulatory programs meet applicable global requirements and uphold the company's high standards of ethical and compliant conduct.

The position focuses on performing compliance reviews, supporting audit preparation and execution, maintaining documentation, and tracking corrective actions. Operating in a highly matrixed, global environment, the incumbent partners with Legal, Compliance, Quality, Regulatory Affairs, and other business functions to monitor adherence to regulatory requirements and contribute to inspection readiness.

• This is a full-time role, Monday through Friday, with an expectation of 2- 3 in-office days per week and additional on-site presence as needed. The individual must reside in the San Diego area and be able to commute to our corporate offices.

Essential Duties and Responsibilities :

Audit Execution & Support

Compliance Monitoring & Program Support

Inspection Readiness

Continuous Improvement & Reporting

Key Competencies :

Regulatory Knowledge : Understands core regulatory frameworks (FDA QSR, ISO 13485, EU MDR, GxP) and their relevance to internal audit and compliance functions.

Analytical Thinking : Uses data, documentation, and observation to identify potential risks or gaps in compliance.

Attention to Detail : Maintains accurate and thorough documentation, ensuring all records meet regulatory expectations.

Collaboration : Works effectively across Legal, Quality, Regulatory, and Operational functions in a global environment.

Integrity & Ethics : Handles sensitive compliance information with discretion and professionalism.

Communication : Prepares clear, concise audit documentation and communicates findings constructively to stakeholders.

Accountability : Manages assigned audit and monitoring tasks independently while meeting established timelines.

Supervisory Responsibilities :

Minimum Qualifications :

Preferred Qualifications :

Other Requirements :