This is a fully remote position, open to applicants in Mexico, +4 more countries.

📋 Description

• Provide guidance to internal teams on adherence to essential US healthcare regulations, including HIPAA/HITECH, the Anti-Kickback Statute, the Stark Law, the False Claims Act, and relevant FDA regulations.

• Draft, assess, and negotiate intricate agreements, such as Clinical Trial Agreements, Business Associate Agreements, Managed Care/Provider contracts, SaaS/Software licenses, vendor agreements, and strategic partnerships.

• Collaborate with Compliance and IT Security to ensure product features, data-sharing processes, and patient interactions comply with HIPAA, state privacy laws, and emerging health data regulations.

• Recognize operational and legal risks associated with product launches, marketing strategies, and clinical integrations, offering practical solutions.

• Manage pre-litigation disputes, supervise regulatory inquiries, and assist in internal compliance investigations.

• Liaise with external specialized counsel regarding regulatory filings, intellectual property, or litigation issues.

⛳️ Requirements

• A Juris Doctor (JD) degree.

• Active bar admission in good standing in at least one US state.

• Over 8 years of legal practice, with considerable experience either in-house at a US medical device, biotech, digital health, or healthcare delivery organization, or within a prominent healthcare practice group at a national law firm.

• Proficiency in navigating key US healthcare frameworks, including HIPAA, Anti-Kickback, Stark Law, and FDA guidelines.

• Demonstrated success in drafting and negotiating complex commercial agreements within the medical or life sciences fields.

• Outstanding communication abilities with the capacity to convert legal concepts into actionable insights for cross-functional business partners.

• Fluency in English is essential.

• CV/Resumé and Cover Letter submissions must be in English.