Overview
This role supports U.S. operations for a medical technology organization developing therapies for spinal cord injury (SCI). The position provides senior legal counsel across commercial contracting, FDA regulatory matters, clinical affairs, healthcare compliance, reimbursement, and market access for Class II/III neurostimulation devices and brain-computer interface (BCI) technologies.
Reporting to the VP Legal based in Switzerland, you will serve as a primary legal business partner to Sales, Marketing, Regulatory Affairs, Clinical Affairs, Market Access, and U.S. leadership.
Preferred location: Nashville or on the East Coast.
Responsibilities
Commercial Contracting, Market Access & HCP Contracting
- Act as primary legal and compliance partner for the U.S. business, delivering practical, risk-based advice to Commercial, Clinical, Regulatory, Market Access, Operations, Compliance, and Executive Leadership.
- Draft, review, and negotiate commercial agreements across care settings and channels, including:
- Customer, hospital, clinic, rehabilitation, distributor, Durable Medical Equipment (DME), vendor
- Strategic partnership, clinical, consulting, and service agreements
- Purchase, lease, rental, subscription, and home-based care models
- Lead legal support for market access activities, including payor contracting with Medicare, Medicaid, and commercial health plans, coverage and reimbursement agreements, prior authorization, and network participation.
- Provide legal and compliance oversight for healthcare professional (HCP) engagements, including consulting, advisory boards, speaker programs, research, and educational activities; ensure Fair Market Value (FMV) requirements and AdvaMed Code compliance are met.
- Advise on healthcare compliance matters related to HCP interactions, anti-kickback and fraud and abuse considerations, transparency reporting, and commercial compliance policies.
- Review advertising, promotional, and marketing materials for compliance with healthcare laws, FDA requirements, substantiation standards, and company policies.
- Develop and maintain contract templates, master service agreements, playbooks, and commercial contracting standards, including compliance requirements.
- Manage commercial and payor due diligence, reimbursement documentation, and Requests for Information (RFI) responses in collaboration with Clinical, Regulatory, Health Economics, Compliance, and IP teams.
FDA Regulatory & Clinical Affairs
- Advise on requirements under the Federal Food, Drug, and Cosmetic Act (FDCA) and FDA regulations for Class II/III medical devices, including BCI technologies.
- Counsel on clinical research compliance (Investigator-Initiated Studies, IDEs, IRB oversight, informed consent, Good Clinical Practice) and negotiate Clinical Trial, Clinical Supply, and Study Agreements with academic institutions, CROs, and clinical sites.
- Review FDA submissions and correspondence from a legal and risk perspective, including IDEs, 510(k)s, De Novo, PMAs, and protocol amendments.
- Advise on FDA enforcement and lifecycle compliance, including inspection readiness, adverse event reporting, recalls, corrective actions, breakthrough designation, real-world evidence, promotional claims, labeling, and interactions with FDA and other regulators.
Procurement & Vendor Management
- Negotiate vendor, distributorship, and commercial partnership agreements; support sourcing of critical suppliers, including due diligence, contractual risk allocation, and legal and regulatory risk assessment.
- Manage IP protection, confidentiality, and technology transfer in supplier relationships.
- Develop and maintain supplier master agreement templates and procurement standards.
Healthcare Compliance & Risk Management
- Develop and implement healthcare compliance policies, procedures, and training programs (HIPAA, AKS, Stark Law, False Claims Act); help ensure a strong culture of compliance across U.S. operations.
- Identify, assess, and mitigate legal and healthcare compliance risks; perform initial legal analyses and collaborate with the global Legal team on specialized matters.
- Advise on adverse event reporting, product recalls, field actions, and post-market compliance obligations, providing legal risk assessment and strategic guidance to support compliant business decisions.
Requirements
- J.D. from an accredited law school.
- Active U.S. state bar license in good standing.
- 8–15 years of progressive legal experience in the healthcare and medical device industry, including:
- At least 3 years at a law firm focused on healthcare/medtech
- 5+ years of in-house medical device experience in a hands-on, execution-oriented legal role
- FDA & Medical Device Regulatory expertise advising on FDA requirements for Class I, II, and III medical devices, including the FDCA and 21 CFR Parts 210/211, 801–807, 812, and 820.
- Experience supporting FDA inspections, Form 483 observations, Warning Letters, enforcement actions, and remediation efforts, including CAPAs, recalls, and regulatory responses.
- Expert in contract drafting and negotiation.
- Experience supporting Clinical Trial Agreements, IDEs, INDs, IRB coordination, and FDA regulatory submissions throughout the product lifecycle.
- Strong knowledge of HIPAA/HITECH, CCPA/CPRA and other state privacy laws, the Anti-Kickback Statute, Stark Law, the False Claims Act, and broader healthcare compliance requirements.
- Experience advising on payer contracting, insurance coverage negotiations, Medicare and Medicaid reimbursement, DME compliance, and Business Associate Agreements (BAAs).
- Strong cross-functional project management skills, with exceptional written and verbal communication skills.
Preferred Qualifications
- Experience with neurotechnology, neuromodulation, implantable medical devices, and neurorehabilitation technologies.
- FDA Breakthrough Device Program experience.
- Patent/IP law background knowledge, BD&L and IP licensing experience.
- Familiarity with international medical device regulatory frameworks (EU MDR, Canada MDSAP).
- Experience in healthcare economics, health outcomes research, or evidence generation.
- Experience at publicly listed, venture-backed, or scaling medtech companies.
- Government/regulatory agency experience (FDA, CMS, DOJ, VA).
Compensation & Benefits
Not specified in the provided description.
Location
Preferred location: Nashville or on the East Coast.