Associate Director, Regulatory Legal Counsel
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* 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
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