AssistantGeneralCounsel,RegulatoryCompliance

## Accountabilities Provide strategic legal counsel on FDA-regulated medical device and in vitro diagnostic products across their full lifecycle, including pre-market and post-market phases Partner with R&D, Quality, Regulatory Affairs, Manufacturing, and Clinical teams to ensure regulatory compliance and mitigate legal and regulatory risk Advise commercial, sales, and marketing teams on product claims, labeling, promotional materials, and launch strategies in compliance with FDA and global regulations Monitor evolving FDA and international medical device regulations and advise leadership on business and compliance implications Support post-market activities including adverse event reporting, field actions, audits, inspections, and product remediation initiatives Guide compliance with GMP/GDP requirements, quality system regulations, and regulatory enforcement matters Provide legal oversight on investigations, regulatory inquiries, and interactions with health authorities Ensure compliance in promotional communications, including on-label and off-label considerations and advertising review processes Requirements: Juris Doctor (J.D.) from an accredited law school and active bar admission in a relevant jurisdiction Extensive experience advising on FDA medical device regulations, including product development, quality systems, and enforcement matters Strong expertise in in vitro diagnostics (IVD), regulatory strategy, and FDA pre-market and post-market requirements Deep knowledge of promotional compliance, labeling regulations, and advertising review for regulated products Experience handling GMP/GDP investigations, audits, and regulatory authority interactions Strong analytical, advisory, and communication skills with the ability to translate regulatory risk into business guidance Ability to collaborate effectively across scientific, technical, and commercial teams 8+ years of experience supporting medical device or diagnostics manufacturers is strongly preferred Fami