Associate Director, Regulatory Legal Counsel
Illumina
Overview
In this senior regulatory role, you provide strategic legal guidance across the lifecycle of Illumina's medical devices, diagnostics, and life-science products in EMEA and Latin America. You collaborate with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced, international setting. You translate complex regulatory rules into actionable guidance for executives and product teams, helping balance compliance with innovation. You will contribute to a mission-driven environment focused on expanding access to genomic technology and improving health outcomes.
Retribuzione / Benefits
- bonus or variable compensation
- equity eligibility
- flexible time off
- private medical insurance (UK)
- pension contribution (UK, 10%)
- life moments support and family-friendly policies
Responsabilità
- Provide regulatory legal advisory and strategy across EMEA and Latin America for medical devices, diagnostics, and life science products
- Interpret EU and UK medical device and IVD frameworks, country-specific requirements, and horizontal regulations
- Assess regulatory risk and support informed business decisions
- Support product lifecycle activities, submissions, market access strategies, and post-market obligations with Regulatory Affairs and Quality
- Advise on regulatory considerations for hardware, software, services, digital solutions, and AI-related requirements
- Support global and regional product lifecycle management
- Review product labeling, promotions, and external communications for regulatory compliance
- Collaborate with Commercial Legal, Compliance, Procurement, IT, and others to assess regulatory aspects in contracts and tenders
- Assist with inspection readiness, regulatory audits, recalls, field actions, and post-market responses
- Monitor regulatory developments and contribute to internal policies, training materials, and governance
- Coordinate external counsel across jurisdictions as needed
Requisiti fondamentali
- Qualified lawyer in the UK, the United States, or an EU Member State
- Significant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciences
- Prior in-house and/or law firm experience advising regulatory clients (preferred)
- Full professional fluency in English; additional languages a plus
- Experience supporting business clients in regulated, international environments
- Experience advising on EU and UK medical device and diagnostics frameworks, including IVDR (preferred)
- Experience with post-market vigilance, inspections, and regulatory authority interactions (preferred)
- Experience collaborating with commercial teams on regulated products
- Ability to work across time zones in a global organization
- Clear, confident communication
- Cross-functional collaboration
- Proactive and adaptable mindset
- Regulatory expertise for medical devices, diagnostics, and life sciences
- EU/UK medical device and IVD frameworks (IVDR)
- Regulatory intelligence and trend analysis
Offerta di lavoro pubblicata 1 giorno fa
Offerte di lavoro simili
- ...Overview In this role you lead the Product Compliance test laboratory in Italy, ensuring ICT hardware meets regulatory and standards requirements. You will manage lab operations and work with standardization bodies to develop and apply compliance standards. You'll...ConsigliatoLavoro ibridoOrario flessibile
31.000 € - 42.000 €
...enterprise Supply Chain Execution software. You'll coordinate with Legal, Privacy & Security and cross-functional teams to align client... ...protection standards. You'll support GDPR, data security and regulatory requirements such as the AI Act, contributing to risk...ConsigliatoOrario flessibile- ...Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure...ConsigliatoRemotoOrario flessibile
- ...Overview As Associate Operations Director at Deel, you will oversee day-to-day operations, optimize performance, and lead cross-functional initiatives... ...Improve fraud prevention, risk management, and regulatory alignment Define and monitor key risk indicators to address...ConsigliatoRemotoOrario flessibile
- Overview In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report...ConsigliatoRemotoOrario flessibile
- Lloyd Morgan China in Umbria, Italy, seeks an experienced Controller to join the plant management team. The Controller will coordinate and supervise administrative and accounting activities at the production site, ensuring compliance with Italian standards and Group policies...
- Overview In questo ruolo creerai e manterrai un framework di conformità per garantire l'allineamento alle normative ICT e di Cybersecurity. Lavorerai all'interno del team Strategy Governance per supportare DPO/CISO/ICT Manager, definire strategie aziendali e piani evolutivi...Part-timeRemotoOrario flessibile
- ...accounts and deferred tax positions Lead design and operation of SOX-compliant tax accounting controls Collaborate with finance, legal, and internal audit to document and test control frameworks Liaise with external auditors and regulators to align on issues and...Orario flessibile
- ...is seeking an Internal Auditor specialising in financial crime to join our Audit team. You will execute internal audits, assess regulatory compliance, and help shape risk management practices within a fast-growing fintech environment. The role focuses on KYC/KYB, AML...
- ...Ability to develop clean, modular, maintainable code with emphasis on reproducibility and quality ~ Autonomy and proactivity with regulatory awareness (EU AI Act), explainability tools, and modern AI architectures ~ Italian and English working proficiency ~...Smart workingOrario flessibile