Associate Director, Regulatory Legal Counsel
Core
Provide strategic legal advice on regulatory requirements for medical devices, diagnostics, and life science products across EMEA and Latin America.
Role type
Senior in-house regulatory legal counsel
Builds
Compliant product development, commercialization, and post-market activities for Illumina's technologies
Domain
Life sciences / Medical technology / Regulatory law
Required skills
Regulatory legal advisory, EU/UK medical device and IVD frameworks, risk assessment, product lifecycle management, contract review, post-market vigilance, regulatory intelligence, training delivery, external counsel management
Preferred skills
Prior in-house or law firm experience, IVDR familiarity, global product development support, commercial team collaboration
Technologies
None stated
Responsibilities
Provide legal guidance on regulatory requirements across EMEA and Latin America; Interpret and advise on EU and UK medical device and IVD regulatory frameworks; Assess regulatory risk across diverse jurisdictions; Partner with Regulatory Affairs and Quality to support product development and submissions; Review and advise on product labeling and marketing materials; Support inspection readiness and post-market vigilance activities; Monitor and analyze evolving regulatory developments; Deliver regulatory legal training to business teams
Seniority
Senior, strategic advisor