Michael Best & Friedrich LLP?s growing Regulatory Practice is looking to add a Senior FDA Attorney with a minimum of 10 years' experience to our experience. The ideal candidate will be located in Washington DC office.but we will accept applications from candidates in Austin, Chicago, Denver, Madison, Milwaukee, Raleigh and SLC. The attorney will serve as a business advisor to clients, guiding them in a full range of legal matters throughout their life cycle. The attorney will also have the opportunity to gain direct client interaction, business development experience, and significant responsibility for complex and sophisticated legal matters The ideal candidate will have experience in the following areas: Preparing and filing FDA submissions for both innovator and generic drugs, and shepherding applications through the approval process; Evaluating legal questions involving marketed unapproved drugs including pre-1938 grandfathered drugs, the DESI program, and the application of the Weiss List; Reviewing OTC drug labeling and promotional materials for FDA compliance and potential regulatory risk; Preparing and filing 510(k) medical device premarket notifications and premarket approval applications; Assist contact lenses manufacturers and sellers with issues related to the PMA approval process, the cGMP requirements of the Quality System Regulation / QSR (21 CFR Part 820), pharmacovigilance or adverse event reporting, labeling and marketing, and evaluation of risk for purposes of conducting a market withdrawal or recall; Understanding the regulation of electronic health records and the digital platforms used for their maintenance and transfer; Strategies to overcome prescription drug approval delays; Advising on product labeling, packaging, and cGMP manufacturing requirements; Product listings and establishment regulations; Responding to FDA warning letters; Preparing clients for FDA and USDA facility inspections; Conducting due diligence reviews prior to sales and acquisitions; Resolving product seizures by U.S. Customs and obtaining removal from import alert list; Product recalls and market withdrawals involving both FDA and USDA regulated products such as Rx drugs, foods, meats, and dairy products; GRAS self-affirmations and notifications; Reviewing advertising and marketing content for compliance with FTC regulations; State food and drug regulatory matters including wholesaler/distributor licensing and registration A minimal portable book of business of at least $500,000 is preferred. The Company We are Michael Best & Friedrich, LLP. We are a full-service law firm with more than 350 lawyers and technical professionals who work in collaborative, interdisciplinary practices to serve clients around the world. We work with companies in all kinds of industries, as well as trade associations, nonprofits, educational institutions, governments, family trusts, and high-net-worth individuals. Since our firm?s founding in 1848, we?ve continuously evolved to meet our clients? changing needs and expectations. One thing remains the same: For generations, clients have relied on Michael Best for exceptional legal service and business acumen. The Location We have offices in Wisconsin (Milwaukee, Madison, Manitowoc, Waukesha); Illinois (Chicago); Utah (Cottonwood Heights, Salt Lake City); Colorado (Denver, Broomfield); Texas (Austin); North Carolina (Charlotte, Raleigh, Wilmington); California (Los Angeles); Nebraska (Lincoln) and Washington D.C. Our contemporary offices spaces are ideal for concentration and collaboration supporting our culture of working together to make great things happen for our clients. Job Requirements: Bring Your Best Knowledge Base & Education: J.D. from an ABA accredited law school Excellent academic credentials 10+ years FDA experience Adaptability: Ability to learn and embrace new skills and best practices as the position evolves and Firm needs change Ability to work well under pressure and meet tight deadlines Ability to work well independently as well as effectively within a team Collaboration: Ability to develop relationships and foster teamwork at all levels of the Firm Communication: Excellent interpersonal skills and ability to work effectively with a diverse group of internal and external clients, attorneys, and staff Excellent oral and written communication skills Ability to manage confidential information and sensitive situations with tact and discretion Problem Solving Skills: Ability and confidence to identify and analyze issues, make decisions, and initiate actions/solutions Agility to respond to unexpected challenges, including proactively developing innovative solutions to complex problems while maintaining a professional demeanor Professionalism Ability to maintain composure and demonstrate good judgment Other Valid authorization to work in the U.S. Minimum portable book of business of $500,000 Why You Should Apply At Michael Best, we are proud to offer a comprehensive and competitive Total Rewards package that provides a variety of resources designed to enhance its employees? overall well-being, both at work and at home. Competitive base pay, outstanding benefits, opportunities for learning and growth, programs designed to help you plan for the future, and perks that inspire your downtime are all part of our total compensation package. Learning and Growth Challenging and Dynamic Role Career Development Planning Professional Growth Opportunities Performance Management and Coaching Specialized Training Programs Mentorship Program Bar Exam/Bar Review Course Reimbursement Health & Wellness Medical Dental Vision Care Health Savings Accounts Flexible Spending Accounts Wellness Program Employee and Family Assistance Program Total Compensation Competitive Base Pay Outstanding Benefits Unlimited PTO Plus 10 Paid Holidays Performance Recognition ABA, State and Local Bar Membership Fee Reimbursement Planning for the Future 401(k) with Company Contribution Short Term Disability Plan Long Term Disability Plan Life Insurance Critical Illness Insurance Parental/Family Leave Culture and Workplace Respected Organization with Collaborative Culture Growing Firm with an Exciting Future Flexible Remote Work Policy (Ability to work remote up to 2.5 days per week) Contemporary Work Environment Positive and Respectful Work Climate To be considered for this position, please submit an application via our online portal. Recruitment agencies: Michael Best is not accepting unsolicited agency resumes for this position. Please do not forward resumes to our careers email address or any Firm employees. Michael Best is not responsible for any fees related to unsolicited resumes. Michael Best & Friedrich LLP, Michael Best Strategies LLC, and Michael Best Consulting LLC (collectively known as "Michael Best") are steadfastly committed to providing equal employment opportunity and maintaining a workplace for employees and applicants for employment that is free from discrimination based upon age, race, religion, color, disability, marital status, sex (including pregnancy), national origin, ancestry, ethnicity, sexual orientation, gender identity or expression, genetic information, veteran or military status, or any other status protected by applicable federal, state, or local law. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, please contact our Recruiting team at 414.225.4999 or careers@michaelbest.com to let us know the nature of your request and your contact information.
Qualification
Juris Doctor (JD)
Practice Areas & Specialty
Compliance/Regulatory, FDA, Food/Beverage
