Senior Legal Counsel

About the Role

ONWARD Medical, a Euronext-listed medical technology company, is seeking a Senior Legal Counsel to support its U.S. operations. This role will lead legal support for commercial, contracting, FDA regulatory matters, clinical affairs, healthcare compliance, reimbursement, and market access for breakthrough Class II/III neurostimulation devices and a world-leading Brain Computer Interface (BCI) platform. The position reports to the VP Legal in Switzerland and serves as the primary legal business partner to Sales, Marketing, Regulatory Affairs, Clinical Affairs, Market Access, and U.S. Leadership. Preferred locations include Nashville or the East Coast.

Responsibilities

• Commercial Contracting, Market Access & HCP Contracting:
  • Serve as the primary legal and compliance partner for the U.S. business, providing 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.
  • 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, ensuring Fair Market Value (FMV) and AdvaMed Code compliance.
  • Advise on healthcare compliance matters, including anti-kickback, fraud and abuse, transparency reporting, and commercial compliance policies.
  • Review advertising, promotional, and marketing materials for compliance with healthcare laws, FDA requirements, 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.
• FDA Regulatory & Clinical Affairs:
  • Advise on FDCA and FDA requirements for Class II/III medical devices, including BCI technologies.
  • Counsel on clinical research compliance (IISs, IDEs, IRB oversight, informed consent, GCP) and negotiate clinical trial agreements.
  • Review FDA submissions and correspondence, including IDEs, 510(k)s, De Novo, PMAs, and protocol amendments.
  • Advise on FDA enforcement, inspection readiness, adverse event reporting, recalls, and post-market compliance.
  • Support breakthrough designation, real-world evidence, promotional claims, labeling, and regulatory interactions.
• Procurement & Vendor Management:
  • Negotiate vendor, distributorship, and commercial partnership agreements.
  • 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).
  • Identify, assess, and mitigate legal and healthcare compliance risks.
  • Advise on adverse event reporting, product recalls, and post-market compliance obligations.

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 healthcare and medical device, 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 legal role.
• Deep expertise in 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, and remediation efforts.
• Expertise in contract drafting and negotiation.
• Experience with clinical trial agreements, IDEs, INDs, IRB coordination, and FDA regulatory submissions.
• Strong knowledge of HIPAA/HITECH, CCPA/CPRA, AKS, Stark Law, False Claims Act, and healthcare compliance.
• Experience in payer contracting, Medicare/Medicaid reimbursement, DME compliance, and BAAs.
• Cross-functional project management and exceptional communication skills.

Qualifications That Make You Stand Out

• Experience with neurotechnology, neuromodulation, implantable devices, and neurorehabilitation.
• FDA Breakthrough Device Program experience.
• Patent/IP law background, BD&L, and IP licensing experience.
• Knowledge of 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 companies.
• Government/regulatory agency experience (FDA, CMS, DOJ, VA).