Legal Counsel

Overview

FDNA is seeking an experienced Legal Counsel to serve as a strategic legal advisor to senior management and operational teams. This role focuses on navigating complex US healthcare regulations, negotiating high-stakes commercial agreements, and mitigating enterprise risk.

The ideal candidate will have deep expertise in federal and state healthcare laws, medical device or clinical operations regulation, data privacy, and commercial contracting across the US medical ecosystem.

Responsibilities

Regulatory & Compliance Strategy

• Advise internal teams on compliance with key US healthcare statutes, including:
  • HIPAA/HITECH
  • Anti-Kickback Statute (AKS)
  • Stark Law
  • False Claims Act (FCA)
  • 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)
  • 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.
• 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

• Juris Doctor (JD) degree
• 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, including:
  • 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

Preferred Qualifications

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

Additional Notes

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