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Fda Consultant Jobs (NOW HIRING)

Alston & Bird's

FDA Technical Consultant

Washington, DC · On-site

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years' experience ...

Alston

FDA Technical Consultant

Washington, DC · On-site +1

Alston & Bird is seeking an experienced FDA consultant to work with the Health Care team's FDA practice out of the Washington, D.C. Office. Qualified candidates will have at least 5 years' experience ...

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How much do fda consultant jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for fda consultant in the United States is $41.55, according to ZipRecruiter salary data. Most workers in this role earn between $29.33 and $49.52 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of an FDA Consultant?

As an FDA Consultant, your days often involve preparing and reviewing regulatory submissions, advising clients on compliance strategies, and staying up-to-date with evolving FDA requirements. You'll work closely with clients in pharmaceutical, medical device, or biotech companies to interpret regulations, conduct gap analyses, and support product development from early stages through post-market compliance. Collaboration with cross-functional teams, such as research, quality assurance, and legal, is common to ensure all processes and documentation meet FDA standards. The work environment is typically a mix of independent analysis and interactive client meetings, offering a balance between technical expertise and strategic consulting.

Is it hard to get hired by the FDA?

Getting hired as an FDA consultant can be competitive due to the specialized knowledge required, such as understanding regulatory guidelines and compliance standards. Candidates often need relevant experience, certifications, and a strong understanding of FDA processes to improve their chances of employment.

How much do FDA consultants make?

FDA consultants typically earn between $80,000 and $150,000 annually, depending on experience, specialization, and location. Senior consultants with extensive regulatory knowledge and certifications can earn higher salaries, often exceeding $200,000. Compensation may also include project-based fees or hourly rates for contract work.

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

To thrive as an FDA Consultant, you need in-depth knowledge of FDA regulations and guidelines, regulatory submission processes, and a relevant science or healthcare background. Familiarity with regulatory databases, document management systems, and certifications like RAC (Regulatory Affairs Certification) are highly valued in this field. Strong analytical skills, attention to detail, and effective communication are key soft skills for advising clients and coordinating with multidisciplinary teams. These skills are essential for ensuring clients achieve compliance, avoid costly delays, and succeed in the highly regulated life sciences industry.

What is an FDA Consultant job?

An FDA Consultant helps businesses navigate FDA regulations to ensure compliance with federal laws related to drugs, medical devices, food, and other regulated products. They provide expert guidance on submissions, approvals, inspections, and regulatory strategies. Their role is crucial for companies seeking to bring products to market while meeting all legal requirements.

What does an FDA consultant do?

An FDA consultant advises pharmaceutical, biotech, medical device, or food companies on compliance with U.S. Food and Drug Administration regulations. They assist with product development, regulatory submissions, audits, and ensuring adherence to safety and quality standards, often requiring knowledge of FDA guidelines and relevant certifications. Their role helps companies navigate complex regulatory processes to bring products to market legally and efficiently.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, with salaries often exceeding $200,000 annually. Other high-paying positions include senior scientists, medical officers, and regulatory directors, especially those with advanced degrees and extensive experience in regulatory affairs or public health.
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Fda Consultant jobs near you
Infographic showing various Fda Consultant job openings in the United States as of June 2026, with employment types broken down into 94% Full Time, 5% Part Time, and 1% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $86,430 per year, or $41.6 per hour.

FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM

Manhattan, NY • On-site

Contractor

Posted 17 days ago

Job description

Freelance FDA Consultant (ISO 13485 & ISO 22716 Experience)
USA Remote (with occasional on-site client visits)
Contract / Self-Employed Basis
About IMSM
IMSM (International Management Systems Marketing) is a global force in ISO consultancy - helping organisations not just achieve certification, but transform the way they operate. We partner with businesses across every sector, elevating performance, boosting compliance and unlocking measurable competitive advantage.
Now part of the Axiom GRC division within the WorkNest group and backed by Inflexion, we bring the reach and resources of a worldwide organisation. With teams spanning the UK, Europe, North America, APAC, Africa and Canada - and a growing network of 85 employees and more than 350 expert contractors enables us to deliver high-quality, results-driven ISO consultancy to clients worldwide.
The Opportunity
We are seeking an experienced FDA Consultant to support regulatory compliance, quality system development, and market readiness activities. The ideal candidate will have deep expertise in FDA regulations alongside hands-on experience implementing and auditing quality systems aligned with ISO 13485 (medical devices) and ISO 22716 (cosmetics GMP).
What You Will Do
  • Provide strategic guidance on FDA regulatory requirements, including submissions, compliance, and inspections
  • Lead or support FDA submissions (e.g., 510(k), cosmetic product compliance, facility registrations)
  • Develop, implement, and maintain Quality Management Systems (QMS) compliant with ISO 13485 and ISO 22716
  • Conduct gap analyses and internal audits to assess compliance readiness
  • Support preparation for FDA inspections and notified body audits
  • Review and author SOPs, technical documentation, and quality records
  • Advise on risk management processes and product lifecycle compliance
  • Ensure alignment between US FDA regulations and international standards
  • Train internal teams on regulatory requirements and quality standards
  • Liaise with regulatory authorities and external stakeholders as needed and have expertise in management systems and relevant standards

What You Will Bring
  • Proven experience as an FDA consultant or regulatory affairs specialist
  • Strong knowledge of FDA regulations (e.g., 21 CFR Parts 210, 211, 820, and cosmetics regulations)
  • RAC (Regulatory Affairs Certification) or equivalent
  • Demonstrated experience with:
    • ISO 13485 (Medical Devices Quality Management Systems)
    • ISO 22716 (Cosmetic Good Manufacturing Practices)
  • Experience supporting FDA inspections and/or notified body audits
  • Excellent documentation, communication, and analytical skills

Join Our Global Contractor Community
As part of the WorkNest group and the wider Axiom GRC division, you will contribute to a powerful network of more than 800 experts shaping the future of Governance, Risk and Compliance services.
If you are a dedicated ISO professional looking for flexible, rewarding work with a market leading consultancy, we would love to hear from you.
Department Operations Locations USA Remote Remote status Hybrid Employment type Contract

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