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Associate Director, Regulatory Legal Counsel
Contract type
Ongoing
Work mode
Remote · United Kingdom, Europe
Experience
Lead / principal · Not stated
Level inferred from job title
Job description
Associate Director, Regulatory Legal Counsel (EMEA & Latin America) at Illumina, providing strategic legal advice across the lifecycle of medical technology products, including RUO and clinical offerings. The role partners with Regulatory Affairs, Quality, Medical Affairs, Compliance, Commercial and Marketing teams across EMEA and Latin America.
At a glance
- Employment
- Full-time · Employee (employment agreement)
- Work mode
- Remote · United Kingdom, Europe
- Languages
- English – fluent
- Pay
- GBP 110,600 – 166,000 / year
What you'll do
- 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
- 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
- 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 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
- 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
What we're looking for
- 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
- Full professional fluency in English
- Demonstrated experience supporting business clients in a regulated, international environment
- Ability to work across time zones in a global organization
Nice to have
- Prior in-house and/or law firm experience advising regulatory clients
- Additional languages
- 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
Your team
global Regulatory Legal team
Illumina's global Regulatory Legal team
Benefits
- Eligible for one of our variable cash programs (bonus or commission)
- Eligible roles may receive equity
Apply
About Illumina
Illumina enables life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Mission
Expanding access to genomic technology to realize health equity for billions of people around the world
Key facts
- EMEALA Head Office in Cambridge, UK