Senior Director, Counsel, Diagnostics & Medical Devices (USA Remote Role)

Overview

This role provides strategic, solutions-oriented legal counsel to support diagnostics and medical device commercial strategy across assigned business units, including the Neuroscience Business Unit. The position focuses on diagnostic and device-related legal matters, including FDA labeling and advertising, fraud and abuse, promotional compliance, antitrust, data privacy, and business transactions.

Responsibilities

• Provide legal counsel and education on FDA labeling and promotional matters for diagnostic products, medical devices, and pharmaceuticals
• Counsel on diagnostics and device-related fraud and abuse, promotional, and antitrust matters for the Neuroscience Business Unit and potentially other business units, as assigned
• Partner with sales and marketing colleagues to advise on device or diagnostic-related patient support and consumer programs consistent with healthcare fraud and abuse laws
• Educate business partners on potential legal implications of proposed marketing tactics for diagnostics and medical devices
• Advise on legal implications related to interactions with third parties relevant to diagnostics and devices, including diagnostics companies and software/digital health companies
• Counsel on sponsored testing programs
• Participate as a core member of leadership teams responsible for diagnostics- and device-related brand and/or product strategies

Requirements (Basic Requirements)

• Bachelor’s degree and JD
• Licensed to practice law in at least one of the 50 States
• Minimum of 7 years of relevant legal experience, including one or more of the following:
  • Practicing as a member of a law firm with a nationally recognized practice in medical devices and in vitro diagnostics
  • In-house experience at a medical device, laboratory, or diagnostics company law department
  • In-house experience at a pharmaceutical or biotechnology company’s law department
  • A combination of the above
  • In-house experience is preferred
• Authorized to work in the United States on a full-time basis
  • The employer will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Preferred Qualifications / Additional Skills and Expertise

• Deep knowledge of FDA laws and regulations pertaining to diagnostics and medical devices (including Medical Device Amendments of 1976 to the FDCA and CLIA, as well as state laws)
• Demonstrated knowledge of device and pharmaceutical marketing laws and regulations as generally practiced by innovative, multinational companies
• Demonstrated experience with fraud and abuse, promotional, and antitrust matters
• Experience evaluating sponsored testing programs for compliance
• Experience evaluating scientific communications and applying principles for communicating truthful and non-misleading scientific information
• Familiarity or experience supporting global marketing and commercialization of diagnostics or pharmaceuticals
• Ability to manage multiple priorities in a fast-paced, evolving environment
• Ability to assess and help business colleagues manage risks in a highly regulated environment
• Strong issue-spotting and sound judgment
• Strong interpersonal skills and ability to partner effectively across teams
• Commitment to teamwork and collaboration
• Excellent oral and written communication skills, including presenting complex information accurately and concisely to influence leaders
• Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency

Compensation & Benefits

• Anticipated wage: $199,500 - $321,200
• Full-time equivalent employees may be eligible for a company bonus (depending, in part, on company and individual performance)
• Comprehensive benefits for eligible employees, including:
  • Eligibility to participate in a company-sponsored 401(k) and pension
  • Vacation benefits
  • Medical, dental, vision, and prescription drug benefits
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • Life insurance and death benefits
  • Certain time off and leave of absence benefits
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Location

• Headquartered in Indianapolis, Indiana (global role supporting assigned business units)
• Travel required: circa 10% (US and possibly limited international)