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.
Requirements
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.