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 2 giorni fa
Offerte di lavoro simili
- ...Compliance Manager role is a full-time role and reports to the Director of Controls & Compliance with significant visibility to... ...is a publicly held global industrial manufacturer with 30,000 associates around the world who help create a better tomorrow by providing...ConsigliatoTempo pienoLavoro ibridoRemoto
- ...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
- ...Brembo è un leader globale nell’innovazione per la mobilità e sviluppa soluzioni avanzate per veicoli e application racing. L’ufficio legale di Bergamo cerca un laureando/neolaureato in Giurisprudenza per supportare redazione contratti e pareri in ambito nazionale e...Consigliato
45.000 € - 65.000 €
pRadiciGroup in Bergamo is seeking a Legal Specialist to provide legal support for international contracts and corporate governance. The successful candidate will manage corporate housekeeping, support legal transactions, and draft various contracts, while mitigating legal...ConsigliatoSmart working- pKIKO MILANO in Bergamo, Italy, seeks a Legal Specialist (Maternity Cover) to join the Legal Corporate Affairs Team, reporting to the Italy Global Real Estate Legal Director. You will support real estate, retail, and marketing contracts to protect the brand and ensure compliance...Consigliato
45.000 € - 50.000 €
pLEGAMI è un brand italiano nato nel 2003, alla ricerca di una figura legale con focus su proprietà intellettuale per supportare lo sviluppo prodotto e la conformità normativa. /ppLa risorsa definirà strategie di tutela IP, coordinerà depositi e opposizioni con consulenti...- ...application of US GAAP and adherence to internal controls across Europe, Middle East and Africa. This full-time hybrid role reports to the Director of Controls Compliance and offers significant visibility to segment CFOs and controllers. /ppYou will lead control reviews,...Tempo pienoLavoro ibrido
- ...The role conducts control reviews, documents procedures, and coordinates with auditors across the EMEA region. Reporting to the Director of Controls & Compliance, this full-time position requires strong SOX knowledge, ERP system experience, and excellent...Tempo pienoLavoro ibrido
- ...Lavoro Mio S.p.A. – filiale di Bergamo cerca un/una legal specialist da inserire nel team di Treviolo. Il ruolo prevede la stesura e revisione di contratti, monitoraggio delle scadenze e archiviazione; fornirà supporto legale ai dipartimenti aziendali e ricerche dottrinali...Tempo pieno
- ...Lavoro Mio S.p.A., filiale di Bergamo, cerca un/una legal specialist da inserire nel team per supporto legale interno. La figura collaborerà nella stesura e revisione di contratti standard, monitorando scadenze, rinnovi e archiviazione digitale. Si richiede Laurea in...Tempo pieno
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...Orario 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...RemotoOrario flessibile
35.000 € - 50.000 €
Siamo una startup fondata nel 2023 da imprenditori seriali: Marco Ogliengo e Francesco Scalambrino hanno già fondato aziende di successo e costruito HR software per aziende “unicorni”. Abbiamo chiuso il più grande round di finanziamento pre‑seed in Italia (4.7M...Lavoro ibrido- ...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...RemotoOrario flessibile
- Uno studio legale di riferimento cerca un legale per fornire consulenza e soluzioni in diverse aree del diritto aziendale. Il candidato ideale avrà almeno 1 anno di esperienza nel ruolo, laurea in giurisprudenza con minimo 105 e buona conoscenza dell'inglese legale. Si...
- ...meeting documentation. Conduct due diligence for M&A transactions and securities offerings. Liaise with external counsel, investment banks, and regulatory bodies as needed. Required Skills & Qualifications: Licensed attorney in good standing with experience in...Tempo pienoRemoto
- 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...RemotoOrario flessibile
- A leading aircraft maintenance provider in Bergamo is looking for a qualified candidate to manage compliance and safety functions. Responsibilities include overseeing safety management systems, developing training, and conducting risk assessments. The ideal candidate should...
- ppGRCteam è una società di consulenza specializzata in Governance, Risk Compliance, che affianca le organizzazioni nella gestione della bconformità normativa /b e della bsicurezza delle informazioni /b. /p pFacciamo parte del bgruppo IMteam /b, che riunisce oltre b150 professionisti...Lavoro ibrido
- Una società di consulenza specializzata in cybersecurity cerca un Cybersecurity Compliance Consultant per affiancare il team in progetti complessi. Il candidato ideale avrà almeno 2/3 anni di esperienza e buona padronanza dell'inglese. Responsabilità includono la definizione...Lavoro ibrido
- 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
- ...Overview In this role, you provide legal support to the Group's functions, focusing on drafting and negotiating key commercial contracts... ..., risk, HSE, insurance, BD, sales) Provide legal opinions on regulatory interpretation and feasibility/enforceability of transactions...Orario flessibile
26.000 € - 52.000 €
...professionale indipendente e multidisciplinare, attiva nella consulenza legale, societaria e finanziaria a supporto di imprese, gruppi... .../ppLa ricerca comprende profili di livello bAssociate, Senior Associate e Manager /b. /ppCompletano il profilo precisione e capacità di...26.000 € - 52.000 €
pHunters Group ricerca un Avvocato/a Corporate / MA per la sede di Bergamo, coinvolto in attività di consulenza in ambito Corporate, MA e diritto societario e commerciale, con autonomia crescente in funzione della seniority. /ppLa funzione prevede operazioni di MA, due ...26.000 € - 52.000 €
Hunters Group ricerca un Avvocato/a Corporate / M&A per la sede di Bergamo, coinvolto in attività di consulenza in ambito Corporate, M&A e diritto societario e commerciale, con autonomia crescente in funzione della seniority. La funzione prevede operazioni di M&A, due...- pPer la strongDirezione Risorse Umane - Legale Lavoro /strong di strongFerrovie dello Stato Italiane S.p.A. /strong ricerchiamo una/un strongResponsabile /strong da inserire nella struttura strongLegal Advisor Area Nord /strong per la sede di strongMilano /strong. /ppLa...
26.000 € - 52.000 €
...esperienza in ambito Corporate / MA, preferibilmente presso studi legali strutturati o realtà professionali con una significativa... .../p pLa ricerca comprende profili di livello bAssociate, Senior Associate e Manager /b. /p pCompletano il profilo precisione e capacità di...- ...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
- ...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
- SIAD S.p.A. cerca una risorsa da inserire nella Funzione Corporate Qualità Sicurezza e Ambiente a Bergamo. La persona coordinerà l’applicazione delle norme ambientali, monitorerà adempimenti normativi e gestirà i processi di sostenibilità, con focus su ISO 14001 e ISO ...Impiego permanente
Ricerche correlate