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Fda Consulting Jobs (NOW HIRING)

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 ...

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 ...

Certified Group

FDA Sampling Supervisor

Melville, NY

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...

DRT Strategies

Technical Writer - FDA

Silver Spring, MD · On-site

DRT Strategies is a consulting firm that provides management consulting and IT solutions to federal agencies and commercial clients. They are seeking a Technical Writer to support the FDA's Center ...

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How much do fda consulting jobs pay per hour?

As of Jun 17, 2026, the average hourly pay for fda consulting in the United States is $52.51, according to ZipRecruiter salary data. Most workers in this role earn between $21.88 and $69.71 per hour, depending on experience, location, and employer.

What is an FDA Consulting job?

An FDA Consulting job involves providing expert guidance to businesses seeking regulatory approval for their products from the U.S. Food and Drug Administration (FDA). Consultants help companies navigate complex FDA regulations, ensure compliance, and prepare necessary documentation for submissions. They may work with pharmaceuticals, medical devices, food, and biotech industries. Their role includes strategy development, risk assessment, and communication with the FDA to facilitate approvals and avoid compliance issues.

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

To thrive in FDA Consulting, you need expertise in regulatory affairs, a deep understanding of FDA guidelines, and often a degree in life sciences or a related field. Familiarity with regulatory submission systems such as eCTD, knowledge of GxP standards, and certifications like RAC (Regulatory Affairs Certification) are valuable. Strong communication, analytical thinking, and project management skills set outstanding consultants apart. These competencies are essential to effectively guide clients through complex regulatory landscapes and ensure successful product approvals.

What does a typical day look like for an FDA Consultant?

As an FDA Consultant, your day might involve reviewing regulatory documentation, preparing submissions for FDA approval, and advising clients on compliance strategies. You’ll often attend meetings with cross-functional teams including R&D, quality assurance, and legal experts to ensure alignment on regulatory requirements. Consultants also stay updated on changes in FDA guidelines, draft correspondence to regulatory agencies, and address client questions or concerns. This dynamic role requires adaptability and strong collaboration skills to manage multiple projects and effectively support clients through all stages of the regulatory process.

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What cities are hiring for Fda Consulting jobs? Cities with the most Fda Consulting job openings:
What are the most commonly searched types of Fda Consulting jobs? The most popular types of Fda Consulting jobs are:
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Fda Consulting jobs near you
Infographic showing various Fda Consulting job openings in the United States as of June 2026, with employment types broken down into 68% Full Time, 9% Part Time, and 23% Contract. Highlights an 89% In-person, 2% Hybrid, and 9% Remote job distribution, with an average salary of $109,227 per year, or $52.5 per hour.

FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM

Manhattan, NY • Remote

Full-time

Posted 18 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.