Overview
A medical technology company specializing in innovative therapies for spinal cord injury (SCI) is seeking a Senior Legal Counsel to support its U.S. operations. The role involves providing legal expertise across commercial, regulatory, clinical, healthcare compliance, reimbursement, and market access matters related to Class II/III neurostimulation devices and brain-computer interface (BCI) technologies. This position reports to the VP Legal based in Switzerland and serves as the primary legal partner to Sales, Marketing, Regulatory Affairs, Clinical Affairs, Market Access, and U.S. Leadership.
Preferred location: Nashville or East Coast of the United States.
Responsibilities
Commercial Contracting, Market Access & Healthcare Professional (HCP) Contracting
- Provide legal and compliance advice to Commercial, Clinical, Regulatory, Market Access, Operations, Compliance, and Executive Leadership teams.
- Draft, review, and negotiate a variety of commercial agreements including customer, hospital, clinic, rehabilitation, distributor, Durable Medical Equipment (DME), vendor, strategic partnership, clinical, consulting, and service contracts.
- Lead market access legal support including payor contracting with Medicare, Medicaid, and commercial health plans, coverage and reimbursement agreements, prior authorization, and network participation.
- Oversee legal and compliance aspects of HCP engagements such as consulting, advisory boards, speaker programs, research, and educational activities ensuring Fair Market Value (FMV) and AdvaMed Code compliance.
- Advise on healthcare compliance matters including 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.
- 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
- Provide counsel on Federal Food, Drug, and Cosmetic Act (FDCA) and FDA requirements for Class II/III medical devices including BCI technologies.
- Advise 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, inspection readiness, adverse event reporting, recalls, corrective actions, post-market lifecycle compliance, breakthrough designation, real-world evidence, promotional claims, labeling, and regulatory interactions.
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 intellectual property 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 covering HIPAA, Anti-Kickback Statute (AKS), Stark Law, False Claims Act, and other relevant regulations.
- Identify, assess, and mitigate legal and healthcare compliance risks.
- Provide legal risk assessment and strategic guidance on adverse event reporting, product recalls, field actions, and post-market compliance obligations.
Requirements
- Juris Doctor (J.D.) from an accredited law school.
- Active U.S. state bar license in good standing.
- 8–15 years of progressive legal experience in healthcare and medical device industry.
- At least 3 years of law firm experience focused on healthcare/medtech and 5+ years of in-house medical device legal experience.
- Deep expertise advising on FDA requirements for Class I, II, and III medical devices, including 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 and recalls.
- Expert contract drafting and negotiation skills.
- Experience with Clinical Trial Agreements, IDEs, INDs, IRB coordination, and FDA regulatory submissions.
- Strong knowledge of HIPAA/HITECH, CCPA/CPRA, Anti-Kickback Statute, Stark Law, False Claims Act, and 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 excellent written and verbal communication.
Preferred Qualifications
- Experience with neurotechnology, neuromodulation, implantable medical devices, and neurorehabilitation technologies.
- Familiarity with FDA Breakthrough Device Program.
- Background knowledge in patent/IP law, business development and licensing.
- Experience with international medical device regulatory frameworks such as EU MDR and Canada MDSAP.
- Healthcare economics, health outcomes research, or evidence generation experience.
- Experience at publicly listed, venture-backed, or scaling medtech companies.
- Government or regulatory agency experience (FDA, CMS, DOJ, VA).
Compensation & Benefits
Details on compensation and benefits are not provided in the job description.
Location
Preferred location is Nashville or anywhere on the East Coast of the United States.