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Attorney-FDA Medical Device Consultant

5 months ago

Denver, United States RightWorks Staffing, Inc Full time
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.