Associate Director, Regulatory Legal Counsel (EMEA & Latin America)
Location: Cambridge - Hybrid
As a key member of Illumina’s global Regulatory Legal team, you will provide strategic and pragmatic legal advice across the full lifecycle of Illumina’s technologies and medical technology products, including 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 translate complex, multi‑jurisdictional regulatory frameworks into clear, business‑focused legal guidance in a fast‑paced, matrixed, international environment.
Employee Benefits
* Flexible time off
* Private medical insurance
* Compassion and care time off
* Leisure travel insurance
* Pension scheme
* Employee stock purchasing program
* Volunteer time off
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; 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 & Education
* Qualified lawyer in the UK, 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.
* Location in the London / Cambridge area preferred.
* Limited regional and international travel may be required.
Equal Employment Opportunity
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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process.
Additional Opportunity
This role is not eligible for visa sponsorship.
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