**Senior Analyst - Regulatory Compliance** **The role** Senior Analyst - Regulatory Compliance 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. adherence to regulatory requirements and contribute to This is an individual contributor role with no direct reports. The Senior Analyst may coordinate tasks or data collection efforts with colleagues and cross-functional stakeholders as needed. **Illumina's employee benefits are industry-leading and include flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more!****Essential Duties and Responsibilities** Support compliance-related training activities and knowledge sharing across teams. **Key Competencies** **Regulatory Knowledge:** Understands core regulatory frameworks (FDA QSR, ISO 13485, EU MDR, GxP) and their relevance to internal audit and compliance functions. **Accountability:** Manages assigned audit and monitoring tasks independently while meeting established timelines. **Minimum Qualifications** 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. **Preferred Qualifications** Experience with electronic Quality Management Systems (eQMS) or audit tracking tools.Familiarity with CAPA management and root cause analysis processes. **Other Requirements** Ability to travel domestically and internationally up to 10% of the time. #J-18808-Ljbffr