[Hiring] Senior Legal Counsel @ONWARD Medical

Role Description

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 matters
• Contracting
• FDA regulatory matters
• Clinical affairs
• Healthcare compliance
• Reimbursement
• 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
• Leadership in the US

Preferred location: Nashville or on the East Coast.

Qualifications

• 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.
• At least 3 years at a law firm focused on healthcare/medtech.
• 5+ 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.
• Expert in contract drafting and negotiation.
• Strong knowledge of HIPAA/HITECH, CCPA/CPRA and other state privacy laws.
• Cross-functional project management skills, with exceptional written and verbal communication skills.

Requirements

• Experience supporting Clinical Trial Agreements, IDEs, INDs, IRB coordination, and FDA regulatory submissions throughout the product lifecycle.
• Experience advising on payer contracting, insurance coverage negotiations, Medicare and Medicaid reimbursement, DME compliance, and Business Associate Agreements (BAAs).
• Experience supporting FDA inspections, Form 483 observations, Warning Letters, enforcement actions, and remediation efforts.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health benefits.
• 401(k) plan with company match.
• Generous paid time off and holidays.
• Opportunities for professional development and growth.