Assistant General Counsel, Regulatory Compliance

Overview

This role provides strategic legal guidance to support the development, authorization, marketing, and lifecycle management of FDA-regulated medical device products, including in vitro diagnostics. The position partners closely with R&D, Quality, Clinical, Regulatory Affairs, Manufacturing, and Commercial teams to mitigate regulatory risk, lead compliance initiatives, and ensure adherence to U.S. and global device regulatory requirements. This position reports to the Vice President and Regulatory Compliance Counsel, Diagnostics Platform and is part of the Diagnostics legal team. The role is fully US remote.

Responsibilities

• Provide legal regulatory counsel to Quality Assurance and Regulatory Affairs teams on product issues, including pre-market and post-market strategies and events
• Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure regulatory compliance throughout the product lifecycle
• Support commercial Sales and Marketing teams by reviewing and advising on promotional materials and product launch strategies
• Monitor evolving FDA and global device regulations and advise leadership on potential regulatory and business implications
• Support post-market activities such as adverse event reporting, field actions, product marketing, inspections, and audits

Requirements

• J.D. from an accredited law school; admission to practice in relevant jurisdiction
• Extensive experience advising on FDA medical device regulations, including product development, Quality System Regulation, product promotion, and enforcement matters
• Strong background in GMP/GDP investigations, FDA pre-market and post-market interactions, IVD and RUO marketing strategies
• Expertise in product promotional communications regulations and compliance, including on- and off-label communications, product labeling, and promotional materials
• Excellent analytical and communication skills
• Ability to travel approximately 10-15%

Preferred Qualifications

• 8+ years supporting medical device manufacturers
• Knowledge of global medical device product regulatory frameworks and industry standards (e.g., ISO 13485, ISO 14971)

Compensation & Benefits

• Annual salary range: $250,000 - $275,000
• Eligibility for bonus/incentive pay
• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees

Location

• Fully US remote

Additional Information

The organization is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Reasonable accommodations are available for applicants and employees with disabilities throughout the application and employment process.