Associate Director, Regulatory Legal Counsel

About this role

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)

The Role

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 and/or law firm experience advising regulatory clients preferred

• Full professional fluency in English; additional languages are a plus

• Demonstrated experience supporting business clients in a regulated, international environment

Preferred Credentials

• Experience advising on EU and UK medical device and diagnostics regulatory frameworks, including IVDR

• Familiarity with post-market vigilance, inspections, and regulatory authority interactions

• Experience supporting global or regional product development and lifecycle management

• Experience working closely with commercial teams on regulated products

Additional Information

• Ability to work across time zones in a global organization

• Preferred location is the UK, with occasional travel required to our Cambridge, UK office (EMEALA Head Office)

• We are also open to considering candidates based in eligible Illumina locations across Europe

• Limited regional and international travel may…