FDA Regulatory Medical Products Associate Attorney (Legal)
Baltimore office of our client seeks FDA regulatory medical products associate attorney with 5 years of regulatory medical products experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will expect to work with primarily in the medical device industry as well as food, dietary supplement, drug, and cosmetic verticals. Conducting legal research, analyzing data, drafting evidence-based opinions and providing oral and written advocacy before government administrative agencies such as the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Customs and Border Protection (CBP). Advise clients and manage with minimal supervision legal and regulatory matters involving medical device Pre-Market Notification (PMN or 510(k)), de novo review process, and pre-submission meeting processes; the Abbreviated New Drug Application (ANDA), the pre-Investigational New Drug (pre-IND) and IND, and the Drug Efficacy Study Initiative (DESI) evaluation processes; medical device and drug product reviews and classifications; and/or Private and public third-party payor and reimbursement regulations; Medical product labeling reviews; indication for use and directions for use counsel and advice; reviews of monographs, scientific and clinical data and other evidentiary reports; regulations governing wholesale distribution of prescription drugs; importation, exportation and supply management of medical products and medical product components; and similar medical products related matters. Coordinate, compile, modify, and draft written responses to federal and state regulatory agencies. Perform legal and regulatory reviews of client files and product materials, draft evidence-based opinions influencing successful importation or exportation of FDA-regulated products. Communicate effectively, professionally, knowledgeably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining an appropriate Firm image. Draft reports and procedure manuals for clients that conform to the prescribed style and format for the purposes of implementing and improving business processes in compliance with regulatory requirements. Understand government agencies regulatory requirements, develop strategies, identify and obtain data and evidence required to support strategies, draft advice and opinions for clients and/or agency for the purposes of bringing the identified product(s) into compliance. Read, analyze, and interpret laws, regulations, and policy under FDA, USDA, Customs and other federal and local regulatory agencies, articles in scientific, regulatory, and technical journals, and legal documents. Provide direct legal representation of clients and support other attorneys in the same before federal and state agencies, courts and third parties. Support business development marketing efforts of the Firm. Must be licensed to practice law in any state and/or the District of Columbia. Knowledge of Microsoft Office software and extensive internet and computers skills for legal research are required. Prior work experience with FDA and/or other government agencies preferred. Spanish, Mandarin, Cantonese or Korean language capabilities preferred.