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Illumina · 9 hours ago

Senior Analyst Regulatory Compliance (San Diego/Hybrid)

San Diego, CA

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $135K/yr

5+ years exp

Illumina is expanding access to genomic technology to realize health equity for billions of people. The Regulatory Compliance Senior Analyst supports the global compliance framework through auditing and monitoring activities, ensuring operations meet regulatory requirements and uphold high ethical standards.

BiotechnologyGeneticsHealth CareMedical

No H1B

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

Qualification

Regulatory KnowledgeCompliance MonitoringAudit ExecutionEQMS ExperienceCAPA ManagementRoot Cause AnalysisAnalytical ThinkingIntegrity & EthicsAccountabilityAttention to DetailCollaborationCommunicationOrganizational Skills

Required

Typically requires a minimum of 5 years of experience in regulatory compliance, quality assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry, with a Bachelor's degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience

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