Description:

FDNA through Nacre Capital is seeking an experienced Legal Counsel with at least 8 years of legal practice, specializing in the United States healthcare and medical industries. In this role, you will serve as a strategic legal advisor to senior management and operational teams, navigating complex healthcare regulations, negotiating high-stakes commercial agreements, and mitigating enterprise risk.
The idóneo candidate possesses deep subject-matter expertise in federal and state healthcare laws, medical device or clinical operations regulation, data privacy, and commercial contracting within the US medical ecosystem.

Key Responsibilities:
• Regulatory & Compliance Strategy: Advise internal teams on compliance with key US healthcare statutes, including HIPAA/HITECH, the Anti-Kickback Statute (AKS), the Stark Law, the False Claims Act (FCA), and FDA regulations (where applicable).
• Commercial & Healthcare Contracting: Draft, review, and negotiate complex agreements, including Clinical Trial Agreements (CTAs), Business Associate Agreements (BAAs),



Managed Care / Provider contracts, SaaS/Software licenses, vendor vendor agreements, and strategic partnerships.
• Data Privacy & Security: Work closely with Compliance and IT Security to ensure all product features, data-sharing pipelines, and patient interactions align with HIPAA, state privacy laws (e.g., CCPA/CPRA), and emerging health data rules.
• Corporate & Risk Management: Identify operational and legal risks across product launches, marketing initiatives, and clinical integrations, providing pragmatic solutions that balance business growth with legal compliance.
• Dispute Resolution & Investigations: Handle pre-litigation disputes, oversee regulatory inquiries, and support internal compliance investigations as needed.
• External Counsel Management: Coordinate with outside specialized counsel on regulatory filings, intellectual property, or litigation matters to ensure cost-effective, high-quality legal

📌 Legal Counsel (México)
🏢 Nacre Capital
📍 México