Assistant General Counsel, Regulatory Compliance
About The Position
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. This position reports to the Vice President and Regulatory Compliance Counsel, Diagnostics Platform and is part of the Danaher Diagnostics legal team. The position will be fully US remote.
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
Nice To Haves
- 8+ years supporting medical device manufacturers
- Knowledge of global medical device product regulatory frameworks and industry standards (e.g., ISO 13485, 14971)
Responsibilities
- Support operating companies’ Quality Assurance and Regulatory Affairs teams by providing legal regulatory counsel on product issues, such as pre-market and post-market strategies and events
- 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
Benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
