Legal Counsel

Nacre Capital; Colombia; Presencial; COP 477 418 000 - 732 041 000; Tempo integral

Resumo da oferta

Nacre Capital, in partnership with FDNA, seeks an experienced Legal Counsel to guide strategic legal decisions in the US healthcare sector. You will navigate HIPAA, privacy rules, and complex regulatory frameworks while shaping commercial agreements.

The role requires 8+ years of experience, a JD, and strong English proficiency to advise senior management and cross-functional teams on risk and regulatory strategy.

Qualificações

• 8+ years of practicing law in healthcare settings or healthcare practice groups
• JD required; US bar admission in good standing preferred
• Experience with HIPAA, AKS, Stark Law, FCA, FDA guidelines preferred
• Ability to draft and negotiate complex commercial agreements in medical sector
• Excellent communication to translate legal concepts for cross-functional teams

Responsabilidades

• Advise on regulatory compliance with US healthcare statutes and FDA regulations
• Draft, review, and negotiate complex clinical trial, BAAs, SaaS licenses, and strategic agreements
• Oversee data privacy and security in line with HIPAA, CPRA, and state laws
• Identify operational and legal risks across product launches and marketing
• Manage external counsel for regulatory filings, IP, or litigation as needed
• Support internal investigations and regulatory inquiries

Conhecimentos

US healthcare regulations

Contract drafting

Data privacy HIPAA

Strong communication

English fluency

Formação académica

Juris Doctor (JD)

US JD a plus

Descrição da oferta de emprego

Description: FDNA through Nacre Capital is seeking an experienced

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

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.