Senior Analyst - Regulatory Compliance

The Senior Analyst - Regulatory Compliance at Illumina supports the global compliance framework by executing and improving auditing and monitoring activities. This hybrid role in Cambridge ensures operations, quality systems, and regulatory programs meet global requirements and ethical standards. Responsibilities include conducting compliance reviews, supporting audits, maintaining documentation, and tracking corrective actions, collaborating with various functions to monitor adherence and prepare for inspections. The role is crucial for upholding the company's high standards of compliant conduct in a highly matrixed, global environment.

Must Have

• Support the planning and coordination of internal audits.
• Assist in developing audit schedules, scoping documentation, and test plans.
• Conduct interviews, gather evidence, and prepare workpapers.
• 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.
• 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.
• Bachelor’s degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
• 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.

Good to Have

• 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.

Perks & Benefits

• 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

Senior Analyst - Regulatory Compliance

Cambridge (Hybrid)

Closing date for applications: 17th December

The role

The 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.

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 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

Audit Execution & Support

• 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.

Compliance Monitoring & Program Support

• 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.

Inspection Readiness

• 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.

Continuous Improvement & Reporting

• 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.

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.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
• 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.
• Certification such as Certified Quality Auditor (CQA), Certified Internal Auditor (CIA), or Regulatory Affairs Certification (RAC) is a plus.

Other Requirements

• Flexible to work across multiple time zones as needed.
• Ability to travel domestically and internationally up to 10% of the time.

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