Senior Regulatory Counsel – Med Devices (EMEA/LA)

Illumina, Inc.; Napoli; Vor Ort; EUR 90.000 - 140.000; Vollzeit

Benefits dieser Stelle

Bonus pay

Equity eligibility

Flexible time off

Private medical insurance

Pension contribution

Life events support

Family-friendly policies

Zusammenfassung

Illumina seeks a senior regulatory legal counsel in Napoli, Campania, to guide the lifecycle of medical devices, diagnostics, and life-science products across EMEA and Latin America. You translate complex regulatory rules into actionable guidance for executives and product teams, balancing compliance with innovation.

You will collaborate across functions, review labeling and communications for regulatory adequacy, coordinate with external counsel, and support global product lifecycle management

Qualifikationen

• Significant regulatory advisory experience in medical devices, med tech, biotechnology, or life sciences.
• In-house and/or law firm experience advising regulatory clients preferred.
• Full professional fluency in English; additional languages a plus.

Aufgaben

• 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.
• 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.

Kenntnisse

Regulatory law expertise

Cross-functional collaboration

Strong communication

Global time-zone coordination

English fluency

Ausbildung

Law degree

Jobbeschreibung

Illumina seeks a senior regulatory legal counsel in Napoli, Campania, to guide the lifecycle of medical devices, diagnostics, and life-science products across EMEA and Latin America. You translate complex regulatory rules into actionable guidance for executives and product teams, balancing compliance with innovation.

You will collaborate across functions, review labeling and communications for regulatory adequacy, coordinate with external counsel, and support global product lifecycle management