Associate Director, Regulatory Legal Counsel

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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 be required

The 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 candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. This salary range applies to the primary posting location listed above. Should the level or location of the role change during the hiring process, the applicable base pay range will be updated accordingly. Compensation ranges for other locations will differ to reflect local market competitiveness and will be shared with candidates if applicable during the recruitment process.

Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.

We offer a thoughtfully designed benefits package that supports your wellbeing, flexibility, and life beyond work—combining globally differentiated offerings with locally tailored programs. This includes support during important life moments, flexible time off, opportunities to give back, and a weeklong company-wide summer shutdown. In the UK, we also offer flexible benefits, a company contribution of 10% into your pension, and private medical insurance, alongside additional benefits to support you and your family.

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 o