This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Assistant General Counsel, Regulatory Compliance based in the United States.
This role plays a critical legal leadership function supporting the development, approval, commercialization, and lifecycle management of FDA-regulated medical device and diagnostic products. You will serve as a key advisor to cross-functional teams spanning R&D, Quality, Regulatory Affairs, Clinical, Manufacturing, and Commercial, ensuring compliance with complex U.S. and global regulatory frameworks. The position focuses on enabling innovation in life sciences while proactively managing regulatory and compliance risk across the product lifecycle. You will provide strategic guidance on pre-market and post-market activities, product claims, and promotional compliance in a highly regulated environment. This is a high-impact role where legal expertise directly influences product safety, market access, and patient outcomes. Operating in a collaborative, science-driven organization, you will help ensure that groundbreaking diagnostic solutions reach the market responsibly and efficiently.
Accountabilities:
- Provide strategic legal counsel on FDA-regulated medical device and in vitro diagnostic products across their full lifecycle, including pre-market and post-market phases
- Partner with R&D, Quality, Regulatory Affairs, Manufacturing, and Clinical teams to ensure regulatory compliance and mitigate legal and regulatory risk
- Advise commercial, sales, and marketing teams on product claims, labeling, promotional materials, and launch strategies in compliance with FDA and global regulations
- Monitor evolving FDA and international medical device regulations and advise leadership on business and compliance implications
- Support post-market activities including adverse event reporting, field actions, audits, inspections, and product remediation initiatives
- Guide compliance with GMP/GDP requirements, quality system regulations, and regulatory enforcement matters
- Provide legal oversight on investigations, regulatory inquiries, and interactions with health authorities
- Ensure compliance in promotional communications, including on-label and off-label considerations and advertising review processes
Requirements:
- Juris Doctor (J.D.) from an accredited law school and active bar admission in a relevant jurisdiction
- Extensive experience advising on FDA medical device regulations, including product development, quality systems, and enforcement matters
- Strong expertise in in vitro diagnostics (IVD), regulatory strategy, and FDA pre-market and post-market requirements
- Deep knowledge of promotional compliance, labeling regulations, and advertising review for regulated products
- Experience handling GMP/GDP investigations, audits, and regulatory authority interactions
- Strong analytical, advisory, and communication skills with the ability to translate regulatory risk into business guidance
- Ability to collaborate effectively across scientific, technical, and commercial teams
- 8+ years of experience supporting medical device or diagnostics manufacturers is strongly preferred
- Familiarity with global regulatory frameworks and standards such as ISO 13485 and ISO 14971 is a plus
- Ability to travel approximately 10–15%
Benefits:
- Competitive annual salary ranging from $250,000 to $275,000 depending on experience and location
- Annual bonus and incentive compensation eligibility
- Comprehensive health coverage including medical, dental, and vision insurance
- Paid time off, holidays, and flexible remote work arrangements
- 401(k) retirement savings plan
- Life, disability, and additional voluntary insurance options
- Opportunity to work fully remotely within the United States
- Exposure to cutting-edge innovation in diagnostics and life sciences
- Inclusive, collaborative environment focused on scientific and societal impact