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ONWARD Medical

Develops ARC Therapy for spinal injury

Senior Legal Counsel

Legal Counsel & Legal SupportConfirmed live in the last 24 hours
Full-timeRemote in USA$210k - $260k /yr

About the Job

Requirements

  • A Juris Doctor degree from an accredited law school and an active U.S. state bar license in good standing.
  • Eight to fifteen years of progressive legal experience in the healthcare and medical device industry, including at least three years at a law firm focused on healthcare or medtech and five or more years of in-house medical device experience in a hands-on, execution-oriented legal role.
  • Deep expertise advising on FDA requirements for Class I, II, and III medical devices, including the Federal Food, Drug, and Cosmetic Act 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.
  • Expertise 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.
  • Cross-functional project management skills.
  • Exceptional written and verbal communication skills.

Responsibilities

  • Lead legal support for commercial, contracting, FDA regulatory matters, clinical affairs, healthcare compliance, reimbursement, and market access for medical devices and the BCI platform.
  • 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, DME, vendor, strategic partnership, clinical, consulting, and service agreements, covering 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.
  • Oversee legal and compliance matters for healthcare professional engagements, including consulting, advisory boards, speaker programs, research, and educational activities, ensuring fair market value requirements and AdvaMed Code compliance.
  • Advise on healthcare compliance matters, including healthcare professional 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, commercial contracting standards, and compliance standards.
  • Manage commercial and payor due diligence, reimbursement documentation, and Requests for Information responses with Clinical, Regulatory, Health Economics, Compliance, and IP teams.
  • Advise on Federal Food, Drug, and Cosmetic Act 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 submissions, 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 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.
  • Develop and implement healthcare compliance policies, procedures, and training programs covering HIPAA, the Anti-Kickback Statute, Stark Law, and the False Claims Act, and support a 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.

Desired Qualifications

  • Experience with neurotechnology, neuromodulation, implantable medical devices, and neurorehabilitation technologies.
  • FDA Breakthrough Device Program experience.
  • Patent and IP law background knowledge, BD&L, and IP licensing experience.
  • Experience with international medical device regulatory frameworks, including EU MDR and Canada MDSAP.
  • Experience in healthcare economics, health outcomes research, or evidence generation.
  • Experience at a publicly listed, venture-backed, or scaling medtech company.
  • Government or regulatory agency experience with FDA, CMS, DOJ, or VA.

About the Company

ONWARD Medical

Develops ARC Therapy for spinal injury

ONWARD Medical develops ARC Therapy, an investigational neurostimulation technology aimed at restoring movement for people with spinal cord injuries. The system uses targeted, programmed stimulation of the spinal cord to re-enable locomotion and may also improve bladder control, sexual function, and blood pressure. The company does not yet sell the device; it licenses its intellectual property and works with leading research institutions to advance its therapy. Unlike many competitors, ONWARD focuses on a proprietary spinal cord stimulation approach and a licensing-based business model built on strong academic partnerships. The ultimate goal is to obtain regulatory approval and commercialization of ARC Therapy to improve outcomes for patients with spinal cord injuries and support healthcare providers and institutions treating them.

Company size
201-500
Company stage
IPO
Headquarters
Eindhoven, Netherlands
Founded
2014

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