Legal Counsel

Overview

FDNA, through the organization, is seeking an experienced Legal Counsel to provide strategic legal advice to senior management and operational teams. This role focuses on navigating complex United States healthcare and medical industry regulations, negotiating high-stakes commercial agreements, and mitigating enterprise risk.

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 agreements
  • Strategic partnerships
• Data Privacy & Security: Partner with Compliance and IT Security to ensure 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; provide 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.

Requirements

• Education: Juris Doctor (JD) degree.
• Bar Admission: Active bar admission in good standing in at least one US state.
• Experience: 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.
• Healthcare Expertise: Experience navigating core US healthcare frameworks, including HIPAA, Anti-Kickback, Stark Law, and FDA guidelines.
• Contracting Experience: Proven track record drafting and negotiating complex commercial agreements in the medical or life sciences sector.
• Communication: Exceptional communication skills, with the ability to translate legal concepts into actionable advice for cross-functional business partners.
• Language: Fluency in English is a MUST.

Preferred Qualifications

• A JD from an accredited US university is good to have but not a must.

Submission Requirements

• CV/Resumé and Cover Letter submissions MUST be in English.