Legal Counsel

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 ideal 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 support. Qualifications &

Requirements

A Juris Doctor (JD) degree A JD from an accredited US university is good to have but not a must. Active bar admission in good standing in at least one US state. 8+ years of practicing law, with significant experience either in-house at a US medical device, biotech, digital health, or healthcare delivery company, or within a recognized healthcare practice group at a national law firm.

Expertise navigating core US 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 with the ability to translate legal concepts into actionable advice for cross-functional business partners. Fluency in English is a MUST Note: CV/Resumé and Cover Letter submissions MUST be in English.