Associate Director, Regulatory Legal Counsel

Illumina; Cambridge; On-site; GBP 90,000 - 130,000; Full time

Job summary

Illumina in the United Kingdom seeks an Associate Director, Regulatory Legal Counsel for EMEA & Latin America to provide strategic regulatory guidance across medical devices, diagnostics, and life sciences products. You will partner with Regulatory Affairs, Quality, Medical Affairs, Compliance, Commercial, and Legal teams to enable compliant product development and post-market activities.

The role requires UK/US/EU qualification, in-house experience, and ability to navigate multi-jurisdictional

Qualifications

• Qualified UK/US/EU lawyer with regulatory expertise in medical devices or life sciences.
• Significant in-house or regulatory advisory experience.
• Experience with EU/UK medical device and IVD frameworks.

Responsibilities

• Regulatory Advisory & Strategy: Provide regulatory guidance on EU/UK medical device and IVD frameworks across EMEA and LATAM; assess risk and support business decisions.
• Product Lifecycle & Market Support: Advise on regulatory considerations for product development, submissions, market access, and post-market obligations.
• Commercial, Marketing & Contractual Support: Review labeling, promotional materials, and contracts for regulatory compliance.
• Post-Market, Inspections & Regulatory Interactions: Prepare for audits, recalls, and post-market actions; respond to authorities.
• Regulatory Intelligence, Training & Governance: Monitor developments and provide training and SOP updates.

Job description

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)

As Associate Director, Regulatory Legal Counsel (EMEA & Latin America) here at Illumina, 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, commercialisation, 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.

Location: The preferred location for this role is the UK, with occasional travel to Illumina's Cambridge, UK office (EMEALA Head Office). We are also open to considering candidates based in eligible Illumina locations across Europe.

Why You

you 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 Responsibilities

• Regulatory Legal Advisory & Strategy
  • Provide legal guidance on regulatory requirements across EMEA and Latin America applicable to medical devices, diagnostics, and life science products.
  • Interpret and advise on EU and UK medical device and IVD regulatory frameworks, country-specific requirements, and horizontal regulations impacting the sector.
  • Assess regulatory risk across diverse jurisdictions and support informed business decision-making.
• Product Lifecycle & Market Support
  • Partner with Regulatory Affairs and Quality to support product development, regional and global submissions, market access strategies, and post-market obligations.
  • Advise on regulatory considerations for hardware, software, services, digital solutions, and emerging technologies, including AI-related regulatory requirements.
  • Support global and regional product lifecycle management activities.
• Commercial, Marketing & Contractual Support
  • Review and advise on product labeling, promotional and marketing materials, and external communications to ensure regulatory compliance.
  • Collaborate with Commercial Legal, Compliance, Procurement, IT, and other stakeholders to assess regulatory considerations in contracts, tenders, licensing, distribution, R&D and procurement activities.
• Post-Market, Inspections & Regulatory Interactions
  • Support inspection readiness, regulatory audits, and post-market vigilance activities.
  • Advise on recalls, field actions, and other post-market corrective activities.
  • Prepare responses to inquiries, inspections, and communications from regional and country-specific regulatory authorities.
• Regulatory Intelligence, Training & Governance
  • Monitor and analyze evolving regulatory developments and trends across EMEA and Latin America.
  • Assist with the development and maintenance of internal policies, SOPs, training materials, and regulatory process improvements.
  • Deliver regulatory legal training and updates to business and functional teams.
  • Coordinate and manage engagement with external counsel in foreign jurisdictions, as required.

Experience and Education

• Qualified lawyer in the UK, the United States, or an EU Member State.
• Significant experience in a regulatory advisory role within the medical device, med tech, biotechnology, or life sciences sector.
• Prior in-house experience.