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- Tasks: Provide strategic legal advice on regulatory matters for groundbreaking medical technologies.
- Company: Join Illumina, a leader in genomic technology and health equity.
- Benefits: Enjoy flexible time off, private medical insurance, and stock purchasing options.
- Other info: Dynamic, inclusive workplace with opportunities for career growth and development.
- Why this job: Make a real impact on global health while working with innovative teams.
- Qualifications: Qualified lawyer with experience in medical device regulations and strong communication skills.
The predicted salary is between 70000 - 90000 ÂŁ per year.
At Illumina, we are expanding access to genomic technology to realise 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.
The Role
As Associate Director, Regulatory Legal Counsel (EMEA & Latin America) here at Illumina in Cambridge, UK, you will be a key member of Illuminaâs global Regulatory Legal team, providing strategic and pragmatic legal advice across the full lifecycle of Illuminaâs 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 crossâfunctional stakeholders to enable compliant product development, commercialization, and postâmarket activities across Europe, the Middle East, Africa, and Latin America. You will play a critical role in translating complex, multiâjurisdictional regulatory frameworks into clear, businessâfocused legal guidance in a fastâpaced, matrixed, international environment.
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 innovationâdriven objectives. You are comfortable advising on evolving regulatory landscapes, including EU and UK medical device and IVD frameworks, and enjoy working crossâfunctionally 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 cuttingâedge 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, countryâspecific requirements, and horizontal regulations impacting the sector
- Assess regulatory risk across diverse jurisdictions and support informed business decisionâmaking
- Partner with Regulatory Affairs and Quality to support product development, regional and global submissions, market access strategies, and postâmarket obligations
- Advise on regulatory considerations for hardware, software, services, digital solutions, and emerging technologies, including AIârelated regulatory requirements
- Support global and regional product lifecycle management activities
- 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
- Support inspection readiness, regulatory audits, and postâmarket vigilance activities
- Advise on recalls, field actions, and other postâmarket corrective activities
- Prepare responses to inquiries, inspections, and communications from regional and countryâspecific regulatory authorities
- 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 inâhouse 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 postâmarket 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.
Associate Director, Regulatory Legal Counsel employer: Illumina
Contact Detail:
Illumina Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Associate Director, Regulatory Legal Counsel
â¨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Illumina. A friendly chat can open doors and give you insights that a job description just can't.
â¨Tip Number 2
Prepare for interviews by understanding Illumina's mission and values. Show how your experience aligns with their goals in genomic technology and health equity. Be ready to discuss how you can contribute to their projects.
â¨Tip Number 3
Practice your pitch! You want to communicate your expertise in regulatory law clearly and confidently. Tailor your examples to highlight your experience with medical devices and international regulations.
â¨Tip Number 4
Don't forget to apply through our website! Itâs the best way to ensure your application gets seen. Plus, it shows you're serious about joining the Illumina team.
We think you need these skills to ace Associate Director, Regulatory Legal Counsel
Some tips for your application đŤĄ
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory law, especially in medical devices and diagnostics. We want to see how your background aligns with the role at Illumina!
Showcase Your Communication Skills: Since this role involves working with various teams and stakeholders, it's crucial to demonstrate your clear and confident communication style. Use examples in your application that showcase how you've effectively engaged with senior leaders or regulators.
Highlight Your International Experience: Given the global nature of this position, emphasise any experience you have working across different jurisdictions, particularly in EMEA and Latin America. We love seeing candidates who can navigate complex regulatory landscapes!
Apply Through Our Website: Don't forget to submit your application through our official website! Itâs the best way for us to receive your details and ensure youâre considered for this exciting opportunity at Illumina.
How to prepare for a job interview at Illumina
â¨Know Your Regulatory Frameworks
Make sure you brush up on the EU and UK medical device and IVD regulatory frameworks. Being able to discuss these in detail will show that you're not just familiar with the regulations, but that you can apply them practically in a business context.
â¨Showcase Cross-Functional Collaboration
Prepare examples of how you've successfully worked with cross-functional teams in the past. Highlight your experience collaborating with Regulatory Affairs, Quality, and Commercial teams to demonstrate your ability to navigate complex environments and drive compliance.
â¨Be Ready for Scenario Questions
Expect scenario-based questions where you'll need to assess regulatory risks or provide legal advice on hypothetical situations. Practise articulating your thought process clearly and confidently, as this will showcase your judgement and strategic thinking.
â¨Communicate Clearly and Confidently
Your communication style is key in this role. Practise explaining complex legal concepts in simple terms, as you'll need to engage effectively with senior leaders and technical experts alike. Confidence in your delivery will make a strong impression.