Role 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:
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Federal and state healthcare laws
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Medical device or clinical operations regulation
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Data privacy
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Commercial contracting within the US medical ecosystem
Key Responsibilities:
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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).
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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, and strategic partnerships.
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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.
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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.
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Dispute Resolution & Investigations:
Handle pre-litigation disputes, oversee regulatory inquiries, and support internal compliance investigations as needed.
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External Counsel Management:
Coordinate with outside specialized counsel on regulatory filings, intellectual property, or litigation matters to ensure cost-effective, high-quality legal support.
Qualifications
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A Juris Doctor (JD) degree
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A JD from an accredited US university is good to have but not a must.
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Active bar admission in good standing in at least one US state.
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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.
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Expertise navigating core US healthcare frameworks (HIPAA, Anti-Kickback, Stark Law, FDA guidelines).
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Proven track record drafting and negotiating complex commercial agreements in the medical or life sciences sector.
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Exceptional communication skills with the ability to translate legal concepts into actionable advice for cross-functional business partners.
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Fluency in English is a MUST.
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Note: CV/ResumΓ© and Cover Letter submissions MUST be in English.