Legal Counsel

Overview

The organization 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 United States healthcare and medical industry 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 within the US medical ecosystem.

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 balancing 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

• 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, and 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 (good to have but not required).

Submission Requirement

• CV/Resumé and cover letter submissions MUST be in English.