Associate Director, Regulatory Legal Counsel

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.Associate Director, Regulatory Legal Counsel (EMEA & Latin America) Cambridge - Hybrid The RoleAs Associate Director, Regulatory Legal Counsel (EMEA & Latin America) here at Illumina in Cambridge, UK, you will be a key member of Illumina’s global Regulatory Legal team, providing strategic and pragmatic legal advice across the full lifecycle of Illumina’s technologies and medical technology products, including both research use only (RUO) and clinical offerings.In this highly visible role, you will partner closely with Regulatory Affairs, Quality, Medical Affairs, Global Compliance, Commercial, Marketing, and other cross‑functional stakeholders to enable compliant product development, commercialization, and post‑market activities across Europe, the Middle East, Africa, and Latin America. You will play a critical role in translating complex, multi‑jurisdictional regulatory frameworks into clear, business‑focused legal guidance in a fast‑paced, matrixed, international environment.Illumina's employee benefitsIllumina'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!Why YouYou are a seasoned regulatory lawyer with deep expertise in medical device, diagnostics, or life sciences regulation, and you thrive in complex, international environments. You bring strong judgment and the ability to balance regulatory risk with commercial and innovation‑driven objectives.You are comfortable advising on evolving regulatory landscapes, including EU and UK medical device and IVD frameworks, and enjoy working cross‑functionally with regulatory, quality, medical, and commercial teams. Your communication style is clear, confident, and practical, allowing you to engage effectively with senior leaders, regulators, and technical experts alike. You are adaptable, proactive, and motivated by supporting cutting‑edge science and technology that improves human health.Key ResponsibilitiesRegulatory Legal Advisory & StrategyProvide legal guidance on regulatory requirements across EMEA and Latin America applicable to medical devices, diagnostics, and life science productsInterpret and advise on EU and UK medical device and IVD regulatory frameworks, country‑specific requirements, and horizontal regulations impacting the sectorAssess regulatory risk across diverse jurisdictions and support informed business decision‑makingProduct Lifecycle & Market SupportPartner with Regulatory Affairs and Quality to support product development, regional and global submissions, market access strategies, and post‑market obligationsAdvise on regulatory considerations for hardware, software, services, digital solutions, and emerging technologies, including AI‑related regulatory requirementsSupport global and regional product lifecycle management activitiesCommercial, Marketing & Contractual SupportReview and advise on product labeling, promotional and marketing materials, and external communications to ensure regulatory complianceCollaborate with Commercial Legal, Compliance, Procurement, IT, and other stakeholders to assess regulatory considerations in contracts, tenders, licensing, distribution, R&D, and procurement activitiesPost‑Market, Inspections & Regulatory InteractionsSupport inspection readiness, regulatory audits, and post‑market vigilance activitiesAdvise on recalls, field actions, and other post‑market corrective activitiesPrepare responses to inquiries, inspections, and communications from regional and country‑specific regulatory authoritiesRegulatory Intelligence, Training & GovernanceMonitor and analyze evolving regulatory developments and trends across EMEA and Latin AmericaAssist with the development and maintenance of internal policies, SOPs, training materials, and regulatory process improvementsDeliver regulatory legal training and updates to business and functional teamsCoordinate and manage engagement with external counsel in foreign jurisdictions, as requiredExperience and EducationQualified lawyer in the UK, the United States, or an EU Member StateSignificant experience in a regulatory advisory role within the medical device, med tech, biotechnology, or life sciences sectorPrior in‑house and/or law firm experience advising regulatory clients preferredFull professional fluency in English; additional languages are a plusDemonstrated experience supporting business clients in a regulated, international environmentPreferred CredentialsExperience advising on EU and UK medical device and diagnostics regulatory frameworks, including IVDRFamiliarity with post‑market vigilance, inspections, and regulatory authority interactionsExperience supporting global or regional product development and lifecycle managementExperience working closely with commercial teams on regulated productsAdditional InformationAbility to work across time zones in a global organizationLocation in the London / Cambridge area preferredLimited regional and international travel may be requiredThe estimated base salary range for the Associate Director, Regulatory Legal Counsel role based in United Kingdom is GBP 110,600 - 166,000. The range reflects long‑term growth in the role; therefore, most candidate