Associate Director, Regulatory Legal Counsel (EMEA & Latin America) Cambridge - Hybrid

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.

The Role
As 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 benefits
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!

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.

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

Illumina is 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.