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 US healthcare 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 Regulatory Expertise: Demonstrated expertise navigating core US healthcare frameworks, including HIPAA, Anti-Kickback, Stark Law, and FDA guidelines.
• Commercial Contracting: 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.
• Application Language Requirement: CV/Resumé and Cover Letter submissions MUST be in English.

Preferred Qualifications

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

Location

Not specified.

Compensation & Benefits

Not specified.