Steven J. Gonzalez
FDA Associate at Hyman, Phelps & McNamara, P.C.- Claim this Profile
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Bio
Experience
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Hyman, Phelps & McNamara, P.C.
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United States
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Law Practice
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1 - 100 Employee
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FDA Associate
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Apr 2022 - Present
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Ropes & Gray LLP
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United States
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Law Practice
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700 & Above Employee
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FDA Associate
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May 2019 - Apr 2022
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Polsinelli
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Law Practice
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700 & Above Employee
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FDA Associate
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Nov 2017 - May 2019
Assist clients in navigating the entire range of pre- and post-market FDA regulations for: food; dietary supplements; pharmaceuticals and biologics; medical devices; cosmetics; and advertising and promotions. Represent companies during FDA inspections and enforcement actions, including responding to FDA Form 483. Provide strategic counsel on rulemaking process and draft public comments to FDA. Advise clients with consumer products regulated by: CPSC, OSHA, EPA, and FTC. Assist clients in navigating the entire range of pre- and post-market FDA regulations for: food; dietary supplements; pharmaceuticals and biologics; medical devices; cosmetics; and advertising and promotions. Represent companies during FDA inspections and enforcement actions, including responding to FDA Form 483. Provide strategic counsel on rulemaking process and draft public comments to FDA. Advise clients with consumer products regulated by: CPSC, OSHA, EPA, and FTC.
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Polsinelli
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Law Practice
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700 & Above Employee
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Summer Associate
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May 2016 - Aug 2016
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Harvard Food Law & Policy Clinic
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Cambridge, Massachusetts
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Clinical Student
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Sep 2015 - Dec 2015
Wrote policy analysis and recommendations for states to prevent diabetes in children by improving participation and nutrition in the USDA Summer Food Service Program and National School Lunch and Breakfast Programs. Wrote policy analysis and recommendations for states to prevent diabetes in children by improving participation and nutrition in the USDA Summer Food Service Program and National School Lunch and Breakfast Programs.
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Conservation Law Foundation
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United States
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Environmental Services
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100 - 200 Employee
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Legal Intern
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May 2015 - Jul 2015
Performed legal research and writing with staff attorneys on a variety of environmental and agricultural matters. Performed legal research and writing with staff attorneys on a variety of environmental and agricultural matters.
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Michael Sullivan & Associates LLP
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United States
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Law Practice
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100 - 200 Employee
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Hearing Representative
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Sep 2012 - Jul 2014
Represented Workers' Compensation insurance carriers, employers, and third-party administrators in negotiations, settlements, and trial appearances. Specifically, handled disputed claims for medical services or products and discovery related costs accumulated by plaintiffs during contested claims.
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Paralegal
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May 2012 - Sep 2012
Assisted attorneys by drafting legal hearing notices, discovery objections, and editing all other correspondence and pleadings written by the attorneys.
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Education
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Harvard Law School
Juris Doctor (J.D.) -
University of California, Santa Barbara
Bachelor’s Degree, Philosophy