Senior Legal Counsel

Overview

This role supports the organization’s growth and U.S. operations as a Senior Legal Counsel. The position provides legal leadership for commercial contracting, market access, FDA regulatory matters, clinical affairs, healthcare compliance, reimbursement, and related legal support for Class II/III medical devices and brain-computer interface (BCI) technologies.

The role will report to the VP Legal located in Switzerland and 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

• Serve as the primary legal and compliance partner for the U.S. business, providing 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 partnerships, and clinical, consulting, and service arrangements.
  • Agreement types include purchase, lease, rental, subscription, and home-based care models.
• Lead market access legal support, 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—ensuring Fair Market Value (FMV) requirements and AdvaMed Code compliance.
• Advise on healthcare compliance matters, including interactions with HCPs, 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 and compliance.
• 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 Federal Food, Drug, and Cosmetic Act (FDCA) and FDA requirements for Class II/III medical devices, including BCI technologies.
• Counsel on clinical research compliance, including Investigator-Initiated Studies, IDEs, IRB oversight, informed consent, and Good Clinical Practice.
• 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 inspection readiness, adverse event reporting, recalls, corrective actions, and post-market lifecycle compliance.
• Support 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 through 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) and ensure strong compliance culture across U.S. operations.
• Identify, assess, and mitigate legal and healthcare compliance risks.
• Conduct 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, and
  • 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).
• 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.
• International medical device regulatory frameworks (EU MDR, Canada MDSAP).
• Healthcare economics, health outcomes research, or evidence generation experience.
• Experience at publicly listed, venture-backed, or scaling medtech company.
• Government/regulatory agency experience (FDA, CMS, DOJ, VA).