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Organization TypeLaw Firm
Years of Experience
Date Last Verified
Medical Devices, Postmarket Compliance Associate, Junior to Mid Level The candidate will work primarily on medical device postmarket compliance and enforcement matters; work on pre-submission matters is also likely. Will operate on a global scale, coordinating among lawyers in offices in all of the world’s major markets to sequence and streamline regulatory approvals. Will be helping companies get new products approved by the Food and Drug Administration (FDA) since the Medical Device Amendments of 1976 were signed into law.
Qualification and Experience
Qualifications: Membership to the CO bar is required. Prefer experience with FDA device enforcement matters, postmarket compliance issues, quality systems requirements, recalls and adverse event reporting. Prior work experience at FDA or in the medical device (including in vitro diagnostics), pharmaceutical or biotechnology industries would be a plus. Scientific, engineering, health or biotech background preferred, but not required. Must have outstanding writing and analytical skills, top academic credentials, enthusiasm for the subject matter, and a commitment to excellence. Desired traits include being a team player, 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, a willingness to “figure it out,” having a superior work ethic, a desire to build and grow relationships, and a positive attitude.
Send a cover letter, resume and law school transcript to the attention.
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