Associate Director, Regulatory Legal Counsel

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) Cambridge - Hybrid

The Role

Illuminas employee benefits

Why You

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 countryspecific requirements and horizontal regulations impacting the sector
• Assess regulatory risk across diverse jurisdictions and support informed business decisionmaking

Product Lifecycle & Market Support

• Partner with Regulatory Affairs and Quality to support product development regional and global submissions market access strategies and postmarket obligations
• Advise on regulatory considerations for hardware software services digital solutions and emerging technologies including AIrelated 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

PostMarket Inspections & Regulatory Interactions

• Support inspection readiness regulatory audits and postmarket vigilance activities
• Advise on recalls field actions and other postmarket corrective activities
• Prepare responses to inquiries inspections and communications from regional and countryspecific 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 inhouse 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 postmarket 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 To learn more visit: 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.