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Melisa Moonan

FDA/Regulatory Compliance and Submissions Expertise

Melisa Moonan is a former FDA attorney with a wealth of experience in the medical device, biologic, tissue, pharmaceutical, and combination product regulatory landscape. Her extensive background spans across various roles including in-house counsel, law firms, and the FDA Chief Counsel's Office. Moonan's expertise covers premarket development strategy, submissions, recalls, adverse event reporting, quality systems, marketing reviews, enforcement, drafting and commenting on legislation, litigation management, materials compliance, due diligence for business transactions, and securities disclosures. Currently seeking in-house counsel or regulatory positions in Upstate NY or consulting opportunities. She is licensed as an attorney in DC and MD, eligible for a NY in-house counsel license.

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Location

Skaneateles, New York