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Michael Best &amp; Friedrich LLP’s growing Regulatory Practice is looking to add a Senior FDA Attorney with a minimum of 10 years’ experience. The ideal candidate will be located in Washington DC 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

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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;

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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;

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

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A minimal portable book of business of at least $500,000 is preferred.

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Location

Washington DC, Austin, Chicago, Denver, Madison, Milwaukee, Raleigh and SLC

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Knowledge &amp; Education

Interpersonal Skills

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

Ability to develop relationships and foster teamwork at all levels of the Firm

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

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

Ability to maintain composure and demonstrate good judgment

Other

Minimum portable book of business of $500,000

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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.

We are committed to fostering an environment where every team member can thrive both personally and professionally. It's why we invest in and provide the following resources and guidance to help you grow your career with confidence.
<ul>
<li>Challenging and Dynamic Role</li>
<li>Career Development Planning</li>
<li>Professional Growth Opportunities</li>
<li>Performance Management and Coaching</li>
<li>Specialized Training Programs</li>
<li>Mentorship Program</li>
<li>Bar Exam/Bar Review Course Reimbursement</li>
</ul>

Learning &amp; Growth

Our comprehensive benefits support the well-being of our people by prioritizing physical and mental health. From core health coverage to proactive wellness programs, we provide the tools you need to care for yourself at every stage of life.
<ul type="disc">
<li>Medical</li>
<li>Dental</li>
<li>Vision Care</li>
<li>Health Savings Accounts</li>
<li>Flexible Spending Accounts</li>
<li>Wellness Program</li>
<li>Employee and Family Assistance Program</li>
</ul>

Health &amp; Wellness

Our approach combines competitive pay with exceptional benefits and meaningful rewards that reflect the value each team member brings to our firm. We ensure everyone has the support they need to be at their best.
<ul>
<li>Competitive Base Pay</li>
<li>Outstanding Benefits</li>
<li>Flexible PTO Plus 10 Paid Holidays</li>
<li>Performance Recognition</li>
<li>ABA, State and Local Bar Membership Fee Reimbursement</li>
</ul>

Total Compensation

We take a proactive approach to future planning by offering benefits designed to safeguard your financial and personal well-being.
<ul type="disc">
<li>401(k) with Company Contribution</li>
<li>Paid medical leave</li>
<li>Long Term Disability Plan</li>
<li>Life Insurance</li>
<li>Critical Illness Insurance</li>
<li>Paid Parental Leave</li>
</ul>

Planning for the Future

Our culture is built on trust, respect, and a shared commitment to excellence. As a growing firm with an exciting vision for the future, we offer a modern, flexible working environment that supports productivity, balance, and connection.
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<li>Respected Organization with Collaborative Culture</li>
<li>Growing Firm with an Exciting Future</li>
<li>Flexible Remote Work Policy</li>
<li>Contemporary Work Environment</li>
<li>Positive and Respectful Work Climate</li>
</ul>

Culture &amp; Workplace

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To be considered for this position, please submit an application via our online portal.

Direct applicants, please apply <a href="https://lawcruit.micronapps.com/sup/ApplicationForm.aspx?%3Eac^?LWCZ4dN=1`&amp;QFBsMzxLV0VYQA%3d%3d=Ml5Kaw%3d%3d&amp;QDFnXTpbVzc%3d=MW4%2bazBQ&amp;PWI4=OF9DRw%3d%3d">here</a>.

If you have any questions about the annunciation please contact: <a href="mailto:careers@michaelbest.com" target="_blank" rel="noreferrer noopener">careers@michaelbest.com</a>

Michael Best &amp; Friedrich LLP and Michael Best Strategies 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 <a href="tel:414.225.4999">414.225.4999</a> or <a href="mailto:careers@michaelbest.com">careers@michaelbest.com</a> to let us know the nature of your request and your contact information.

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Senior FDA Attorney

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