Senior Director, Counsel, Diagnostics & Medical Devices
About the role
For our client, we are seeking a Senior Director, Counsel, Diagnostics & Medical Devices to join the team of a leader in the Pharmaceuticals & Biotech space. This senior legal role will provide strategic counsel to business leaders supporting diagnostics and medical devices, with a strong focus on FDA-related labeling, promotional, and compliance matters. The position will partner closely with commercial teams to help guide lawful marketing practices, manage risk, and support business objectives in a highly regulated environment. You will also advise on third-party interactions, sponsored testing programs, and broader regulatory issues that arise across device and diagnostics strategies.
Location and compensation
Remote — US-based candidates only; no visa sponsorship available. Compensation: $199,500 – $321,200 annually.
Responsibilities
- Provide legal counsel on FDA labeling and promotional matters for diagnostics and medical devices.
- Advise on fraud and abuse, promotional, and antitrust issues for the business unit.
- Collaborate with sales and marketing to ensure compliance with healthcare laws.
- Educate business partners on legal implications of marketing tactics.
- Advise on interactions with third parties in diagnostics and digital health.
- Counsel on sponsored testing programs.
- Participate in leadership teams for diagnostics and device strategies.
Qualifications
- Juris Doctor (JD) and a bachelor's degree required.
- Licensed to practice law in at least one U.S. state.
- Minimum of 7 years of relevant legal experience in medical devices or diagnostics, preferably in-house.
- Deep understanding of FDA laws and regulations related to diagnostics and medical devices.
- Experience with fraud and abuse, promotional, and antitrust matters.
Benefits
- Eligibility for a company-sponsored 401(k) and pension.
- Comprehensive medical, dental, vision, and prescription drug benefits.
- Flexible spending accounts for healthcare and dependent care.
- Life insurance and death benefits.
- Well-being benefits including employee assistance programs and fitness benefits.