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New York City office of our client seeks healthcare/regulatory counsel/ attorney with experience. The candidate must have prior government (FDA or similar government agency) experience as well as experience practicing within the medical device/pharmaceutical manufacturer space. Legal

Lauded as an excellent firm for which to work, this firm has been cited as a top firm for minority and diversity hiring. In the same vein, the firm is praised for its open culture and the wonderful individuals who make it up. Throughout its history, the firm has featured excellent real estate, business, litigation, tax, and employment practices, with the latter being an especially strong suit. With its origins in Los Angeles, the firm has offices across the world and industry-leading clients from over 80 countries, but has not lost its open and friendly culture.

Washington, D.C. office of our client seeks mid-level FDA regulatory attorney with experience. The candidate must have substantial experience in pharmaceutical and/or medical device regulatory issues, including one or more of the following areas: the Hatch-Waxman and Biosimilars regulatory schemes (approval criteria, labeling, and exclusivities); product development and clinical trials; regulation of advertising and promotion for medical products (including fraud and abuse issues); GMP/QSR compliance and enforcement; device classification, clearance and approval processes. Must have experience in FDA dispute resolution procedures and administrative (APA) litigation. Substantial experience in pharmaceutical and/or medical device regulatory issues is needed. Legal

Transferable skills and a strong academic background from a nationally recognized law school. Exceptional written and oral communication skills are a must.

This Amlaw firm is best known for allowing its associates to find a balanced work load that best suites them. As a result, the company operates with an entrepreneurial culture, offers flexible face-time, and values diversity and a work space inclusive of everyone. This firm is also one that values pro-bono work?encouraging their associates to gain real-life experience and take charge of their own opportunities and success.

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. Legal

Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions; Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe; Excellent organizational, document and docket management skills; Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors; Flexible, eager to learn, and able to manage the dynamic environment and rapid change; Maintains an appropriate firm image in all client communications; Administrative and marketing duties such as drafting blogs, press releases, and presentations, attending conventions, and speaking events is needed. J.D. degree from an ABA accredited law school is required.

New York City office of our client seeks health law/ FDA associate attorney with 1-2 years of experience. The candidate will be working with other firm attorneys on all aspects of regulatory advising and counseling FDA-regulated entities in the life sciences, health care, and consumer product industries, including analyzing products in development for applicable regulatory requirements or approval pathways; advising clients on available expedited pathways for products in order to support strategic corporate decision-making; reviewing product packaging, labeling, and advertising for compliance with applicable requirements; drafting and commenting on certain transaction documents and securities filings for FDA-regulated entities; performing regulatory due diligence and supporting transaction teams by assessing compliance with regulatory requirements under various proposed corporate structures; and supporting the products liability litigation team by analyzing regulatory framework for the products implicated in a private plaintiff or class action complaint. Will draft or review contracts with FDA-associated regulatory implications, such as pharma co-vigilance agreements, quality agreements with contract manufacturers, and clinical trial agreements and may also be involved in responding to FDA enforcement actions against clients or government-led investigations of client products or manufacturing facilities. Experience researching, analyzing, and advising on FDA regulatory matters for various prescription or provider-administered products (drugs, biologics, medical devices, or diagnostics); other health care regulatory matters (Sunshine Act compliance, clinical trial processes and procedures, protection of human subjects); or broader Federal health care fraud and abuse matters (the Anti-Kickback Statute, the Stark Law, the False Claims Act, the Prescription Drug Marketing Act) is strongly preferred. Professional experience working within the FDA, the HHS Office of Inspector General, the Centers for Medicare and Medicaid Services, or any other government agency overseeing health care or life sciences companies is also preferred. Legal

The candidate must possess a strong academic background and strong research, writing, and interpersonal skills and a commitment to client service.

This mid-sized New York law firm is a multidisciplinary firm with a regional, national and international practice. Attorneys deliver professional legal services in traditional areas such as litigation, business law, real estate, public finance, commercial law, tax, financial planning and labor. Associates begin their first year with an extensive orientation program and then are assigned a mid-level associate in their practice area who will serve as a mentor throughout the first year. There is an entrepreneurial spirit throughout the work environment. Attorneys here are guided by an abiding respect for professional excellence and collegiality while emerging as an active, innovative and progressive law firm.

Washington, D.C. office of our client seeks health law/FDA associate attorney with 1-2 years of experience. The candidate will be working with other firm attorneys on all aspects of regulatory advising and counseling FDA-regulated entities in the life sciences, health care, and consumer product industries, including analyzing products in development for applicable regulatory requirements or approval pathways; advising clients on available expedited pathways for products in order to support strategic corporate decision-making; reviewing product packaging, labeling, and advertising for compliance with applicable requirements; drafting and commenting on certain transaction documents and securities filings for FDA-regulated entities; performing regulatory due diligence and supporting transaction teams by assessing compliance with regulatory requirements under various proposed corporate structures; and supporting the products liability litigation team by analyzing regulatory framework for the products implicated in a private plaintiff or class action complaint. Will draft or review contracts with FDA-associated regulatory implications, such as pharma co-vigilance agreements, quality agreements with contract manufacturers, and clinical trial agreements and may also be involved in responding to FDA enforcement actions against clients or government-led investigations of client products or manufacturing facilities. Experience researching, analyzing, and advising on FDA regulatory matters for various prescription or provider-administered products (drugs, biologics, medical devices, or diagnostics); other health care regulatory matters (Sunshine Act compliance, clinical trial processes and procedures, protection of human subjects); or broader Federal health care fraud and abuse matters (the Anti-Kickback Statute, the Stark Law, the False Claims Act, the Prescription Drug Marketing Act) is strongly preferred. Professional experience working within the FDA, the HHS Office of Inspector General, the Centers for Medicare and Medicaid Services, or any other government agency overseeing health care or life sciences companies is also preferred. Legal

Must possess a strong academic background and strong research, writing, and interpersonal skills and a commitment to client service.

Based in Boston, this firm is among the fastest growing firms in the land. With a huge, posh, Washington office, this firm presents a unique opportunity to take advantage of their growth in a variety of areas, especially Intellectual Property and litigation. Great pay and benefits provide a nice incentive to contribute to this firm's success!

Washington, D.C. office of our client seeks corporate (FDA regulatory) attorney with 3-6 years of experience. The candidate will join the firm's Health Care and Life Sciences Practice Group. Legal

Should have strong academic credentials, possess outstanding writing skills, enjoy significant client contact and a desire to join a dynamic, diverse and fast paced practice area.

Boasting a large presence in the corporate and litigation arenas, exceptional training programs and an innovative partner assessment program, the firm is a major hit with associates. At this firm, associates learn exactly what it means to practice law--and have a breadth of appreciation for all elements of a large full service practice. In their posh DC offices, the environment is professional and polished.

Miami office of our client seeks FDA associate attorney with 5+ years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct legal research, analyze data, draft evidence-based opinions and provide 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). Manage FDA-related legal matters independently with minimal supervision including: Advise clients and manage with minimal supervision legal and regulatory matters involving food, food ingredients, the generally recognized as safe (GRAS) notification process, dietary supplements, dietary ingredients, new dietary ingredient (NDI) notifications, food and dietary supplement good manufacturing practices (GMP) regulations recall management and assistance, FDA 483 and Warning Letter response, case management and representation (multiple industries), product labeling reviews; product website and marketing reviews, importation, exportation and supply management of FDA-regulated products; and similar FDA-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, knowledgably, 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 is preferred. Legal

Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions. Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe. Excellent organizational, document and docket management skills. Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors. Flexible, eager to learn, and able to manage the dynamic environment and rapid change. Maintains an appropriate firm image in all client communications. Administrative and marketing duties such as drafting blogs, press releases, and presentations, attending conventions, and speaking events. J.D. degree from an ABA accredited law school is needed. Knowledge of Microsoft Office software and extensive internet and computers skills for legal research are required.

Long Island office of our client seeks associate attorney with 5 years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct 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 CBP Liquidated Damages Claims Petitions, Offers in Compromise, CBP civil seizure actions, CBP holds, detentions and investigations, CBP requests (CF-28, CF-29), FTA applicability and documentation, and similar CBP and trade-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 products. Communicate effectively, professionally, knowledgably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining the 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 Customs, FDA, FAA, USDA, DOT, 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. Maintains relevant credentials required for the position. Participates in CLE and maintains leading-edge knowledge and skills in their area of expertise, as required. Must be licensed to practice law in any state and/or the District of Columbia. Prior work experience with FDA and/or other government agencies is preferred. Spanish, Mandarin, Cantonese or Korean language capabilities are preferred. Legal

Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions. Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe. Excellent organizational, document and docket management skills. Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors. Flexible, eager to learn, and able to manage the dynamic environment and rapid change. J.D. degree from an ABA accredited law school is needed.

Baltimore office of our client seeks associate attorney with 5 years of regulatory experience. The candidate will manage FDA-related legal and regulatory matters for domestic and international clients. Will work with food, dietary supplement, drug, cosmetic and medical device industry verticals. Conduct 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 CBP Liquidated Damages Claims Petitions, Offers in Compromise, CBP civil seizure actions, CBP holds, detentions and investigations, CBP requests (CF-28, CF-29), FTA applicability and documentation, and similar CBP and trade-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 products. Communicate effectively, professionally, knowledgably, and in a timely manner both orally and in writing to managers, colleagues, clients, and government agencies maintaining the 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 Customs, FDA, FAA, USDA, DOT, 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. Maintains relevant credentials required for the position. Participates in CLE and maintains leading-edge knowledge and skills in their area of expertise, as required. Must be licensed to practice law in any state and/or the District of Columbia. Prior work experience with FDA and/or other government agencies is preferred. Spanish, Mandarin, Cantonese or Korean language capabilities are preferred. Legal

Strong interpersonal skills with the ability to influence and achieve successful results through effective interactions. Excellent research and writing skills, extensive internet skills for legal research, and advanced experience using MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe. Excellent organizational, document and docket management skills. Excellent communication and mechanical writing skills free of typographical, grammatical, and punctuation errors. Flexible, eager to learn, and able to manage the dynamic environment and rapid change. J.D. degree from an ABA accredited law school is needed.

Uniondale office is seeking an IP attorney with experience in the food and beverage industry on FDA and FTC regulations. Candidate will manage the trademark prosecution process including conducting trademark clearance searches, drafting memoranda on trademark search results, providing guidance on viability of registration, filing trademark applications and responding to Office Actions. Candidate will also review product labeling, website copy, marketing and advertising material for compliance with the FDCA, DSHEA and FTC. Must be admitted in NY. Legal

This national law firm offers a full range of consulting services for their clients. Their areas of practice include litigation, intellectual property, business services, appellate, alternative dispute resolution, wills, trusts, estates, labor, employment law, and more. Their offices are located in Albany, Buffalo, Ithaca, New York City, Syracus, Saratoga Springs, Uniondale, and Melville, NY; New Haven, CT; and Newark, NJ.