Description
We are seeking a junior to mid-level associate to join our Medical Devices group within the Food, Drug, Medical Device and Agriculture practice in our Washington, D.C. office.
The successful candidate will work at the forefront of medical device regulation, advising clients across a broad spectrum of premarket and post-market compliance, enforcement, and strategic regulatory matters.
Responsibilities:
- Provide strategic guidance on FDA regulatory pathways
- Support the preparation and submission of premarket applications, including 510(k) notifications, Investigational Device Exemptions (IDEs), De Novo classification requests, and Premarket Approval Applications (PMAs)
- Assist clients in navigating FDA review processes, including responding to deficiency letters and other agency inquiries
- Work on post-market compliance matters, including quality system regulation issues, recalls and field corrective actions, adverse event reporting and vigilance obligations, and broader FDA enforcement and compliance strategies
- Develop practical, forward-looking strategies for bringing innovative technologies to market while managing regulatory risk in a dynamic environment
Requirements:
- Demonstrated interest in FDA regulatory law and medical device issues
- Experience with FDA medical device matters is strongly preferred
- Admitted to the District of Columbia Bar
- Outstanding writing and analytical skills, strong academic credentials, and a commitment to excellence
- Thoughtful and practical problem solvers with excellent judgment, strong communication skills, and the ability to convey complex regulatory concepts clearly and effectively
Benefits:
- Competitive salary ($235,000 to $310,000 per year)
- Annual performance bonuses and discretionary bonuses
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Paid time off
- Relocation assistance may be available
We are an Equal Opportunity Employer and welcome applications from qualified candidates.