Legal Counsel

About the role

FDNA, in partnership with Nacre Capital, is looking for an experienced Legal Counsel to guide senior management and operational teams through the complex landscape of U.S. healthcare regulations, commercial agreements, and enterprise risk.

Key responsibilities

• Advise internal teams on compliance with HIPAA/HITECH, the Anti‑Kickback Statute, Stark Law, the False Claims Act, and applicable FDA regulations.
• Draft, review, and negotiate Clinical Trial Agreements, Business Associate Agreements, Managed Care contracts, SaaS licenses, vendor agreements, and strategic partnerships.
• Collaborate with Compliance and IT Security to align product features and data‑sharing pipelines with HIPAA, state privacy laws (e.g., CCPA/CPRA), and emerging health‑data rules.
• Identify and mitigate operational and legal risks across product launches, marketing initiatives, and clinical integrations.
• Handle pre‑litigation disputes, oversee regulatory inquiries, and support internal compliance investigations.
• Coordinate with external counsel on regulatory filings, intellectual property, and litigation to ensure cost‑effective, high‑quality support.

Required profile

• Juris Doctor (JD) degree; JD from a U.S. university is a plus but not mandatory.
• Active bar admission in good standing in at least one U.S. state.
• 8+ years of legal practice, preferably in‑house at a medical device, biotech, digital health, or healthcare delivery company, or in a national healthcare practice group.
• Deep expertise in core U.S. healthcare frameworks (HIPAA, Anti‑Kickback, Stark Law, FDA guidelines).
• Proven track record drafting and negotiating complex commercial agreements in the medical or life‑sciences sector.
• Exceptional communication skills and fluency in English.

Required skills

• HIPAA/HITECH compliance
• Anti‑Kickback Statute (AKS)
• Stark Law
• False Claims Act (FCA)
• FDA regulatory knowledge
• CCPA/CPRA data‑privacy expertise