Senior Analyst Regulatory Compliance

Cambridge - UK

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Senior Analyst - Regulatory Compliance

Cambridge (Hybrid)

Closing date for applications: 17th December

The role

TheSenior Analyst - Regulatory Compliancesupports Illuminas global compliance framework through the execution and continuous improvement of compliance auditing and monitoring activities. This role ensures that Illuminas operations quality systems and regulatory programs meet applicable global requirements and uphold the companyshigh standardsof ethical and compliant conduct.

The position focuses on performing compliance reviews supporting audit preparation and executionmaintainingdocumentation and tracking corrective actions. Operating in a highly matrixed global environment the incumbent partners with Legal Compliance Quality Regulatory Affairs and other business functions tomonitoradherence to regulatory requirements and contribute toinspectionreadiness.

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.

Illuminas employee benefits are industry-leading and include flexible time off private medical insurancecompassionand 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.

Assistin developing audit schedules scoping documentation and test plans.

Conduct interviews gather evidence and prepare workpapers to support audit conclusions.

Evaluate audit findings document observations andassistin tracking corrective and preventive actions (CAPAs) through closure.

Maintain organized audit records and ensuretimelyfollow-up with stakeholders.

Compliance Monitoring & Program Support

Support the implementation and maintenance of Illuminas Regulatory Compliance Program.

Assistin monitoring compliance metrics reporting results andidentifyingtrends or recurring issues.

Contribute toupdatesofpolicies procedures and work instructions to ensure alignment with current regulatory standards.

Assistin supporting other elements of Illuminas Compliance Program efforts globally as called upon.

Inspection Readiness

Maintain audit andinspectionreadiness documentation ensuring accuracy and accessibility.

Assistin the coordination of regulatory inspections and external audits (e.g. FDA ISO EU MDR).

Support response preparation document retrieval and inspectionlogistics.

Continuous Improvement & Reporting

Prepare andmaintaincompliancedashboards reports and summaries for management review.

Identifyopportunities 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 MDRGxP) and their relevance to internal audit and compliance functions.

Analytical Thinking:Uses data documentation and observation toidentifypotential risks or gaps in compliance.

Attention to Detail:Maintainsaccurateand 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

Bachelors degree in Life Sciences Chemistry Regulatory Affairs ora relateddiscipline.

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 andGxP.

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.

#LI-HYBRID

#INDUK

We are a company deeply rooted in belonging promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation Illumina has always prioritized openness collaboration and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay regardless of gender ethnicity or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences increase cultural awareness and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex race creed color gender religion marital status domestic partner status age national origin or ancestry physical or mental disability medical condition sexual orientation pregnancy military or veteran status citizenship status and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local state and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local state and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process please contact To learn more visit: The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.

Required Experience:

Senior IC

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