Back to jobs
Associate Director, Regulatory Legal Counsel
CambridgePosted 1 weeks ago
Full-timehybriddirector
Job Description
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.
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.
Associate Director, Regulatory Legal Counsel (EMEA & Latin America) Cambridge - Hybrid
The Role
As Associate Director, Regulatory Legal Counsel (EMEA & Latin America) here at Illumina in Cambridge, UK, 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, commercialization, 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.
Illumina's employee benefits
Illumina's employee benefits are industry-leading and include, flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more!
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
- 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.