Posted: 15 Dec 2015 06:36 AM PST
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Melisa M. C. Moonan has joined the firm as Of Counsel.
Ms. Moonan advises clients on medical device regulatory issues. She joined the firm after close to six years as Associate Chief Counsel for Regulatory Affairs at Welch Allyn, a medical device manufacturer. In that role, Ms. Moonan was responsible for guiding the company in meeting FDA and Global Regulatory Authorities’ requirements for medical devices, including obtaining premarket registrations and assuring postmarket compliance. She advised management across company departments including Regulatory, Quality, R&D, Marketing, and Operations on premarket strategy and submissions, state licensing, traditional and social media marketing campaigns, quality systems issues, Medical Device Reporting, field actions and reporting, inspections and 483 responses, and writing and reviewing agency submissions generally. She also helped spearhead the company’s global product materials compliance effort including on REACH and California Proposition 65 compliance, and advised the company on regulatory issues related to acquisitions. Ms. Moonan won a number of company awards for her work on product development projects, registrations, and 483 responses.
Prior to Welch Allyn, Ms. Moonan was in private practice as an FDA Counsel at two major law firms, and served as Associate Chief Counsel for Biologics in FDA’s Office of Chief Counsel from 1994-1998. At FDA, Ms. Moonan successfully litigated food, drug, and FOIA cases, and advised CBER on rules and policies related to regulation of the blood supply, medical devices, diagnostics, and therapeutics, including working on the regulations and policies for ASRs, HCT/Ps, and blood establishment software.
Ms. Moonan graduated with honors from the University of Maryland School of Law, and earned a Bachelor of Arts in History from Brown University. She is admitted to practice in the District of Columbia and Maryland.
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