Associate Director, Regulatory Legal Counsel

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Associate Director, Regulatory Legal Counsel (EMEA & Latin America) Cambridge - Hybrid The RoleIllumina's employee benefitsWhy YouKey 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
• Location in the London / Cambridge area preferred
• Limited regional and international travel may be required

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 opportunities to engage in social responsibility. We are proud to be 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. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.