Regulatory Counsel – Med Devices & Diagnostics (EMEA/LATAM)

Illumina

Bardi

In loco

EUR 120.000 - 180.000

Tempo pieno

2 giorni fa

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Descrizione del lavoro

Illumina seeks a senior Regulatory Legal Counsel to provide strategic legal guidance across the lifecycle of medical devices, diagnostics, and life-science products in EMEA and Latin America. The role collaborates with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced international setting.

The ideal candidate is a qualified lawyer with significant regulatory advisory experience in med tech or life sciences, fluent in English,

Competenze

Must be a qualified lawyer in the UK, the United States, or an EU Member State.
Significant regulatory advisory experience in medical devices, diagnostics, or life sciences.

Mansioni

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.
Coordinate external counsel across jurisdictions as needed.