Assistant General Counsel, Regulatory Compliance
New
Based in the United StatesFull-TimeSenior
Salary250,000 - 275,000 USD per year
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Job Details
- Experience
- 8+ years
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%
Responsibilities
- 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
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