Senior Analyst Regulatory Compliance (San Diego/Hybrid)

Illumina • San Diego, CA

36d • Hybrid

About The Position

What if the work you did every day could impact the lives of people you know? Or all of humanity? 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 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.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
• Minimum of 5 years of experience in regulatory compliance, quality assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry.
• Working knowledge of global regulatory standards such as FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and GxP.
• Experience supporting internal or external audits, inspections, or compliance monitoring activities.
• Strong organizational, communication, and documentation skills.
• Flexible to work across multiple time zones as needed.
• Ability to travel domestically and internationally up to 10% of the time.

Nice To Haves

• Experience with electronic Quality Management Systems (eQMS) or audit tracking tools.
• Familiarity with CAPA management and root cause analysis processes.
• Certification such as Certified Quality Auditor (CQA), Certified Internal Auditor (CIA), or Regulatory Affairs Certification (RAC) is a plus.

Responsibilities

• Support the planning and coordination of internal audits across functions and regions.
• Assist in developing audit schedules, scoping documentation, and test plans.
• Conduct interviews, gather evidence, and prepare workpapers to support audit conclusions.
• Evaluate audit findings, document observations, and assist in tracking corrective and preventive actions (CAPAs) through closure.
• Maintain organized audit records and ensure timely follow-up with stakeholders.
• Support the implementation and maintenance of Illumina's Regulatory Compliance Program.
• Assist in monitoring compliance metrics, reporting results, and identifying trends or recurring issues.
• Contribute to updates of policies, procedures, and work instructions to ensure alignment with current regulatory standards.
• Assist in supporting other elements of Illumina's Compliance Program efforts globally as called upon.
• Maintain audit and inspection readiness documentation, ensuring accuracy and accessibility.
• Assist in the coordination of regulatory inspections and external audits (e.g., FDA, ISO, EU MDR).
• Support response preparation, document retrieval, and inspection logistics.
• Prepare and maintain compliance dashboards, reports, and summaries for management review.
• Identify opportunities to improve audit efficiency and consistency.
• Support compliance-related training activities and knowledge sharing across teams.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Number of Employees: 5,001-10,000 employees