Assistant General Counsel, Regulatory Compliance

About the role

The Assistant General Counsel provides strategic legal guidance to support the development, authorization, marketing, and lifecycle management of FDA-regulated medical device products, including in vitro diagnostics. This role 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.

Responsibilities

• Partner with R&D, Quality, Regulatory, and Operations teams to ensure regulatory compliance across 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
• Provide support for 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

Essential Requirements

• Ability to travel – approximately 10-15%
• Previous experience in supporting medical device manufacturers
• Knowledge of global medical device product regulatory frameworks and industry standards (e.g., ISO 13485, 14971)

Pay

The annual salary range for this role is $250,000 - $275,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

Benefits

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.