Attorney-FDA Medical Device Consultant - 1743097

The Denver office of US LLP is seeking a junior to mid-level associate to join our Medical Devices group of our Food Drug, Medical Device and Agriculture practice to work primarily on medical device postmarket compliance and enforcement matters; work on pre-market matters is also likely.  Prefer experience with FDA device enforcement matters, postmarket compliance issues, quality systems requirements, recalls, adverse event reporting, distribution agreements, regulation and commercialization of software as a medical device, and state licensing.  Prior work experience at FDA or in the medical device (including in vitro diagnostics), pharmaceutical or biotechnology industries would be a plus but is not required. 

Scientific, health, biotech, software, or engineering background preferred, but not required.  Applicants must have outstanding writing and analytical skills, top academic credentials, and a commitment to excellence. Desired traits include being a team player, having excellent legal analysis and communication skills (effective, concise, and articulate written and verbal skills), being extremely responsive and client-service oriented, being a quick learner, having a superior work ethic, enthusiasm for the work, and a positive attitude.