Über diese Associate Director, Regulatory Legal Counsel Stelle bei Illumina
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
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.
