Senior Legal Counsel

ONWARD Medical•,

1d•Hybrid

About The Position

ONWARD Medical is a Euronext-listed medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI). Building on more than a decade of scientific discovery and clinical research, ONWARD is pioneering targeted spinal cord stimulation and breakthrough brain-computer interface (BCI) technologies designed to unlock recovery after paralysis. As we scale our U.S. operations, we are building a world-class legal function to support commercial growth, clinical innovation, and regulatory excellence while partnering with the SCI community to bring life-changing therapies to patients. To support Onward Medical’s growth and its operations in the USA, we are looking for a Senior Legal Counsel. In this role, you will lead legal support for commercial, contracting, FDA regulatory matters, clinical affairs, healthcare compliance, reimbursement, and market access for our breakthrough Class II/III neurostimulation devices and world-leading Brain Computer Interface (BCI) platform. Reporting to the VP Legal who is located in Switzerland, you'll serve as the primary legal business partner to Sales, Marketing, Regulatory Affairs, Clinical Affairs, Market Access, and to our Leadership in the US. Preferred location: Nashville or on the East Coast.

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: deep 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 to maintain compliance and mitigate legal risk.
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.

Nice To Haves

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).

Responsibilities

Serve as the primary legal and compliance partner for the US 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 — customer, hospital, clinic, rehabilitation, distributor, Durable Medical Equipment (DME), vendor, strategic partnership, clinical, consulting, and service — including 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 are met.
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.
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 (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, inspection readiness, adverse event reporting, recalls, corrective actions, and post-market lifecycle compliance, as well as breakthrough designation, real-world evidence, promotional claims, labeling, and interactions with FDA and other regulators.
Negotiate vendor, distributorship, and commercial partnership agreements, and support sourcing of critical suppliers — 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.
Develop and implement healthcare compliance policies, procedures, and training programs (HIPAA, AKS, Stark Law, False Claims Act); ensure strong culture of compliance across US operations.
Identify, assess, and mitigate legal and healthcare compliance risks; conduct initial legal analyses and collaborate with 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 and effective business decisions.