At a Glance
- Tasks: Provide strategic legal advice on regulatory matters for medical technologies across EMEA and Latin America.
- Company: Join Illumina, a leader in innovative medical technology with a collaborative culture.
- Benefits: Enjoy flexible time off, private medical insurance, and a range of employee perks.
- Other info: Work in a dynamic environment with opportunities for career growth and international collaboration.
- Why this job: Make a real impact in healthcare by navigating complex regulatory landscapes.
- Qualifications: Qualified lawyer with experience in medical device regulations and strong communication skills.
The predicted salary is between 80000 - 100000 £ per year.
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 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 accommodations@illumina.com.
Associate Director, Regulatory Legal Counsel in Cambridge employer: Dormont Manufacturing Co
Illumina is an exceptional employer, offering a dynamic work environment in Cambridge that fosters collaboration and innovation. With industry-leading benefits such as flexible time off, private medical insurance, and opportunities for professional growth through Employee Resource Groups, employees are empowered to thrive both personally and professionally. The company's commitment to diversity and inclusion, alongside its focus on cutting-edge science and technology, makes it a rewarding place to contribute to advancements in human health.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Regulatory Legal Counsel in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory and legal fields, especially those who work at Illumina or similar companies. A friendly chat can sometimes lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and UK medical device regulations. Be ready to discuss how you’ve navigated complex regulatory landscapes in the past. Show them you’re not just a lawyer, but a strategic partner!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds and shows your professionalism.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of the Illumina team. Let’s get you that dream job!
We think you need these skills to ace Associate Director, Regulatory Legal Counsel in Cambridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director role. Highlight your experience in regulatory law, especially in medical devices and diagnostics, to show us you’re the perfect fit!
Showcase Your Expertise:We want to see your deep understanding of EU and UK regulatory frameworks. Use specific examples from your past roles to demonstrate how you've navigated complex regulations and provided strategic legal advice.
Be Clear and Concise:When writing your application, keep it straightforward. We appreciate clarity, so avoid jargon and get straight to the point about your skills and experiences that align with the job description.
Apply Through Our Website:Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity.
How to prepare for a job interview at Dormont Manufacturing Co
✨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 can also translate them into practical advice for the business.
✨Showcase Cross-Functional Collaboration
Prepare examples of how you've successfully worked with teams like Regulatory Affairs, Quality, and Commercial in the past. Highlighting your ability to partner across functions will demonstrate that you can thrive in a matrixed environment, which is crucial for this role.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or product lifecycle issues. Think through potential scenarios beforehand and be ready to articulate your thought process and decision-making skills clearly.
✨Communicate Clearly and Confidently
Practice articulating complex legal concepts in a straightforward manner. This role requires clear communication with senior leaders and regulators, so being able to convey your ideas confidently will set you apart from other candidates.
