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Fda Regulatory Attorney Jobs (NOW HIRING)

NxT Level

Associate, FDA Regulations - DC

Washington, DC · On-site

$365K/yr

... FDA Regulatory Associate with 4-5 years of experience to join its Health & Life Sciences Practice Group in Washington, DC. This is an outstanding opportunity for a motivated attorney to advise a ...

NxT Level

Associate, FDA Regulations - DC

Washington, DC · On-site

$225K/yr

... FDA Regulatory Associate with 4-5 years of experience to join its Health & Life Sciences Practice Group in Washington, DC. This is an outstanding opportunity for a motivated attorney to advise a ...

The Rockridge Group

FDA Attorney

Pine Brook, NJ · On-site +1

FDA ATTORNEY POSITIION: DIRECT HIRE Firm X, established in 2000, is a national boutique law firm ... Compounding rules, regulations and FDA guidance o 503A o 503B o Bulk API suppliers and repackagers ...

Jobot

Senior FDA Attorney

Pine Brook, NJ · On-site +1

$250K - $400K/yr

A nationally recognized boutique law firm focused exclusively on healthcare and life sciences is seeking an experienced FDA Attorney to join its growing regulatory practice. This Jobot Job is hosted ...

Foxstone Recruiting

FDA Partner

Washington, DC · On-site

The firm offers a Chambers-ranked regulatory platform, exceptional financial performance, and a ... FDA regulatory and compliance * Branded pharmaceutical products * Pharmacy and compounding pharmacy

Alaska Department of Law

$200 - $250/hr

... FDA regulatory issues * Familiarity with U.S. Department of Justice, Federal Trade Commission ... Our attorneys benefit from a hybrid work environment (three days in-office), a "dress for your day ...

W3Global Inc.

Regulatory Associate

Boston, MA · Remote

$235K - $310K/yr

Experienced Attorneys Employment Type: Full-Time Practice Area: FDA Regulatory, Healthcare & Consumer Products Department: Regulatory & Compliance Locations: * Boston, MA * New York, NY * Palo Alto ...

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Fda Regulatory Attorney information

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$137.4K

$199K

How much do fda regulatory attorney jobs pay per year?

As of Sep 8, 2026, the average yearly pay for fda regulatory attorney in the United States is $137,408.00, according to ZipRecruiter salary data. Most workers in this role earn between $100,000.00 and $166,000.00 per year, depending on experience, location, and employer.

What does an FDA Regulatory Attorney do?

An FDA Regulatory Attorney advises clients on compliance with regulations set by the U.S. Food and Drug Administration (FDA). They assist companies in industries such as pharmaceuticals, medical devices, food, and cosmetics to navigate regulatory approvals, labeling requirements, and enforcement actions. Their work often involves reviewing submissions to the FDA, handling inspections, and ensuring products meet legal requirements. They may also represent clients in litigation or administrative proceedings related to FDA regulations.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Attorney?

To thrive as an FDA Regulatory Attorney, you need a strong background in law with experience in FDA regulations, compliance, and life sciences, typically supported by a JD degree and state bar admission. Familiarity with regulatory submission systems, research databases, and knowledge of electronic document management tools are important technical assets. Outstanding attention to detail, problem-solving abilities, and persuasive communication skills set top candidates apart. These competencies are crucial for navigating complex regulatory processes, advising clients, and ensuring legal compliance in highly regulated industries.

What are some typical daily responsibilities of an FDA Regulatory Attorney?

As an FDA Regulatory Attorney, your daily responsibilities often include advising clients or internal teams on regulatory compliance, preparing and reviewing submissions to the FDA, and interpreting new or updated regulations. You may also collaborate closely with scientists, quality assurance professionals, and business leaders to assess risks and develop strategies for product approvals or compliance matters. Regular activities can involve drafting legal documents, managing responses to agency inquiries, and staying updated on recent FDA guidance. The role is dynamic and requires coordinating across different departments and occasionally negotiating with regulatory authorities.

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Fda Regulatory Attorney jobs near you
Infographic showing various Fda Regulatory Attorney job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $137,408 per year, or $66.1 per hour.

FDA Regulatory Attorney - Class III IVD / Companion Diagnostics

Axiom Talent Platform

OR • On-site, Remote

$309K/yr

Full-time

Medical, Dental, Vision, PTO

Re-posted 28 days ago

Job description

We are seeking an experienced FDA Regulatory Attorney with deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client, a Fortune 500 clinical laboratory. This person will serve as the primary FDA-facing regulatory lead, driving strategy and execution for complex submissions and lifecycle management in close partnership with cross-functional and partner teams.

Key Responsibilities:

  • Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.
  • Own strategy, drafting, and management of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions.
  • Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.
  • Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling, and other post-market obligations).
  • Support product classification and premarket strategies for 510(k)-regulated IVDs, including Q-Sub preparation.
  • Partner with cross-functional teams (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals.
  • Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics.

Qualifications:

  • J.D. and active license to practice law in at least one U.S. jurisdiction.
  • At least five years of in-house experience at a medical device or diagnostics company is preferred. 
  • Direct ownership of Class III PMA IVD and/or companion diagnostic submissions (strategy, drafting, and FDA interaction).
  • Recent, hands-on experience with Modular PMAs, FDA Q-Subs, PCCPs, SIRs, and lifecycle PMA strategy.
  • Strong knowledge of FDA regulations and guidance for Class III PMA devices, IVDs, and companion diagnostics; familiarity with 510(k) pathways for IVDs preferred.
  • Proven ability to act as the primary FDA-facing regulatory lead, work cross-functionally, and communicate clearly with technical and business stakeholders.

Compensation: 

The estimated total compensation for full-time Axiom attorney roles is $104,500-325,000 per year and for non-attorney roles is $71,250-309,750 per year. Compensation decisions are based on various factors, including, but not limited to, experience, skills, certifications, location, and business needs.  Employees may be eligible for additional benefits, including health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities and tools. 

About Axiom: 

For over 25 years, Axiom has pioneered the alternative legal services industry, now serving more than 1,500 legal departments globally with our unique blend of world-class legal talent and advanced AI tools, delivering innovative solutions ranging from that combine top-tier talent with cutting-edge technology. We tackle complex legal matters across 12 practice areas for clients ranging from Fortune 100 to SMBs, empowering our legal professionals to engage in meaningful work that advances their careers. Our Talent NPS score of +71% and our Client NPS score of +64% highlight our commitment to excellence (Reported scores were Axiom's average for 2025 - the legal industry average NPS score is +35%). Join our forward-thinking community where you'll keep your career dynamic and multi-faceted, be part of a company that values agility, collaboration, and excellence, and love both the law and your life. 

Learn more about life at Axiom.  

Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today's business landscape with best in class alterative legal services.   

Diversity is core to our values and we are proud to be an equal opportunity employer. Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender, gender identity, gender identity status, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. 

Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require accommodations to participate in each stage of the recruitment process. To request an accommodation, please contact benefits@axiomlaw.com. 

Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full data privacy notice is available here.    

Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. Pursuant to the San Francisco Fair Chance Ordinance, NY Fair Chance Act, and Los Angeles Fair Chance Initiative, we will consider for employment qualified applicants with arrest and conviction records.   

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