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Fda Regulatory Attorney Jobs (NOW HIRING)

Preferred Qualifications * 7+ years of legal experience as a practicing attorney, including at a law firm, in-house, or in government. * Deep understanding of the FTC and FDA regulatory framework for ...

Preferred Qualifications * 7+ years of legal experience as a practicing attorney, including at a law firm, in-house, or in government. * Deep understanding of the FTC and FDA regulatory framework for ...

Preferred Qualifications * 7+ years of legal experience as a practicing attorney, including at a law firm, in-house, or in government. * Deep understanding of the FTC and FDA regulatory framework for ...

Senior Counsel -US Rare Tumors

Boston, MA ยท On-site

$188K - $283K/yr

Serve as lead attorney for a key brand of the Rare Tumors Therapeutic area, including: review of ... Compliance & Regulatory Oversight: Ensure all activities comply with FDA, OIG, CMS, and state ...

Our team seeks to add a dynamic lawyer with good verbal and written skills to assist in healthcare ... of FDA-regulated products. Ideal candidates will have demonstrated experience in healthcare ...

Senior Counsel -US Rare Tumors

Boston, MA ยท On-site

$188K - $283K/yr

Serve as lead attorney for a key brand of the Rare Tumors Therapeutic area, including: review of ... Compliance & Regulatory Oversight: Ensure all activities comply with FDA, OIG, CMS, and state ...

Because the NKNA Legal Department already employs two Contracts attorneys, a Paralegal, and a ... Medical Device regulatory experience, including general knowledge of FDA regulatory matters and ...

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Fda Regulatory Attorney information

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$69K

$137.4K

$199K

How much do fda regulatory attorney jobs pay per year?

As of Jun 24, 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 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.

What are the key skills and qualifications needed to thrive in the Fda Regulatory Attorney position, and why are they important?

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 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.

More about Fda Regulatory Attorney jobs
What cities are hiring for Fda Regulatory Attorney jobs? Cities with the most Fda Regulatory Attorney job openings:
What states have the most Fda Regulatory Attorney jobs? States with the most job openings for Fda Regulatory Attorney jobs include:
Senior Product Counsel San Francisco, CA (Hybrid) (971-SLS)

Senior Product Counsel San Francisco, CA (Hybrid) (971-SLS)

Solutus Legal Search

San Francisco, CA โ€ข On-site

$216K - $324K/yr

Full-time

Life, Retirement

Posted 19 days ago


Job description

Our client, a publicly traded digital health company leveraging technology and AI to transform care delivery, has exclusively retained Solutus Legal Search to assist the executives in their search for a Senior Product Counsel. This role reports to the Associate General Counsel, Product, and will work closely with other members of the Legal & Compliance team, as well as cross-functional stakeholders across the organization - including access to senior leadership.
In this role, you will serve as a strategic legal partner to the company's Product, R&D, Hardware, Marketing, and Clinical teams as they develop and launch innovative new products and services in the healthcare space. You will be advising on the full spectrum of legal and regulatory issues that arise as the company scales innovative digital health products and services - including an FDA-cleared device, AI-driven care platform, and global offerings. This is a high-impact, individual contributor role for an experienced attorney who can independently navigate complex and ambiguous legal and regulatory landscapes, drive business initiatives forward, and deliver practical, business-enabling legal counsel.
Responsibilities include:
  • Enable product and business initiatives. Collaborate with Product, R&D, Engineering, Marketing, Hardware, Clinical, and other stakeholders throughout the organization to understand, advise on, and drive forward new products, services, technologies, and processes impacting the company's business and members. Serve as a trusted, business-enabling legal partner from brainstorm through launch.
  • Own FDA and medical device legal work. Advise the hardware and product teams on FDA regulatory requirements, including 510(k)/de novo submissions, new indications, device modifications, clinical research, and regulatory inquiries. Manage the legal work related to the company's FDA-cleared medical devices and help avoid enforcement actions.
  • Advise on global expansion. Coordinate with international outside counsel to advise on legal and regulatory requirements across multiple countries and territories. Identify barriers to international product launches, develop creative compliance solutions, and own the global legal workstream for the Product Legal team.
  • Provide guidance on healthcare regulatory and government programs. Advise on legal frameworks applicable to government programs (e.g., Medicare, VA, TRICARE), first dollar coverage (FDC) eligibility, CARES Act implications, and government contracting issues.
  • Support marketing and commercial claims. Review marketing materials, claims, and messaging for legal and regulatory compliance, including FDA promotional requirements, FTC guidelines, and truth-in-advertising standards.
  • Protect the company from unnecessary risk. Proactively identify legal and regulatory issues in company initiatives, think creatively to develop solutions, and collaborate cross-functionally to help the business move forward while managing risk.
  • Develop resources and generate efficiencies. Create and maintain legal resources, guidance documents, FAQs, and trainings to aid internal teams in developing and launching products and services.
  • Stay ahead of the regulatory landscape. Keep up-to-date on legal and regulatory developments relevant to digital health, medical devices, and provision of care and ensure key stakeholders are promptly advised on potential risks and opportunities.

Experience includes:
  • J.D. from an ABA-accredited law school
  • Licensed to practice law in at least one U.S. jurisdiction
  • 5-7 years of experience advising on healthcare legal and regulatory matters, with a strong preference for product counsel experience in the digital health, health tech, or medical device space
  • Demonstrated expertise in FDA regulations and medical device requirements (e.g., 510(k) process, device modifications, promotional compliance)
  • Experience using AI tools to enhance and accelerate deliverables
  • Experience and comfort with working at both an operational and strategic level.
  • Experience advising on international product launches and navigating multi-jurisdictional regulatory frameworks (e.g., EU MDR/IVDR, UK medical device regulations, Health Canada)
  • Familiarity with government contracting requirements (FAR, FEHBAR, TAA) and programs such as Medicare, Medicaid, VA, and TRICARE
  • In-house experience at a technology or digital health company, combined with law firm experience at a nationally recognized firm
  • Strong track record of cross-functional collaboration and ability to communicate complex legal and regulatory concepts in a clear, business-friendly manner
  • Self-starter who thrives working independently; comfortable with ambiguity and shifting priorities

The role offers a competitive compensation package, including a base salary range of $216,000 - $324,000, together with eligibility for equity participation. The company also offers comprehensive benefits, including retirement plans with company match, modern life stipends, and support for family and wellness needs. Total compensation is designed to align with the scope and impact of the position.
Solutus Legal Search is proud to have been exclusively retained to assist our client with this special engagement. Resumes submitted directly to our client will be forwarded to Solutus Legal for evaluation.
Ref. 971-SLS
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.