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Remote Fda Auditor Jobs (NOW HIRING)

Agilent

... FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements. Develop audit strategies, plans, and reports ... Willingness to travel globally up to 50%; role may be remote or site-based within the EU/UK. Pay ...

IQVIA

Sr. Clinical QA Auditor

Washington, DC · Remote

$75K - $188K/yr

Overview The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced ... remote audits, ensuring alignment with regulatory requirements (FDA, EMA, ICH-GCP) * Design and ...

IQVIA

Sr. Clinical QA Auditor

Washington, DC · Remote

$75K - $188K/yr

Overview The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced ... remote audits, ensuring alignment with regulatory requirements (FDA, EMA, ICH-GCP) * Design and ...

SQA Services

Quality Auditor - Pharmaceutical

Boston, MA · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

SQA Services

Quality Auditor - Pharmaceutical

Butler, PA · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

SQA Services

Quality Auditor - Pharmaceutical

Buffalo, NY · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

SQA Services

Quality Auditor - Pharmaceutical

Bohemia, NY · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

SQA Services

Quality Auditor - Pharmaceutical

Avon, NY · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

SQA Services

Quality Auditor - Pharmaceutical

Hanover, NH · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

SQA Services

Quality Auditor - Pharmaceutical

Concord, NH · Remote

$1K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ...

Genstar Capital LLC

Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report ... Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness ...

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Remote Fda Auditor information

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$33K

$76.3K

$121.5K

How much do remote fda auditor jobs pay per year?

As of Jun 9, 2026, the average yearly pay for remote fda auditor in the United States is $76,256.00, according to ZipRecruiter salary data. Most workers in this role earn between $53,500.00 and $98,500.00 per year, depending on experience, location, and employer.

What are some common challenges faced by Remote FDA Auditors, and how can they be managed effectively?

Remote FDA Auditors often encounter challenges such as limited access to physical documents, time zone differences with global clients, and ensuring secure communication. To manage these effectively, auditors should familiarize themselves with digital audit tools, establish clear communication protocols with clients, and stay updated on remote auditing best practices. Proactive planning and strong organizational skills are essential for success in this role.

What is the difference between Remote Fda Auditor vs Remote Quality Assurance Specialist?

AspectRemote Fda AuditorRemote Quality Assurance Specialist
CertificationsFDA auditor certification, GxP, GMP, GLPISO, Six Sigma, GMP, GCP
Work EnvironmentRegulatory agencies, pharmaceutical, biotech companiesManufacturing, clinical trials, healthcare companies
Industry UsagePrimarily in pharma, biotech, medical devicesBroader across healthcare, manufacturing, biotech

The Remote Fda Auditor focuses on ensuring compliance with FDA regulations through audits of facilities and processes, mainly in pharma and biotech industries. The Remote Quality Assurance Specialist oversees quality systems, policies, and procedures across various healthcare sectors. While both roles require knowledge of GMP and regulatory standards, the Fda Auditor emphasizes compliance verification, whereas the QA Specialist concentrates on maintaining quality standards throughout the organization.

What are Remote FDA Auditors?

Remote FDA Auditors are professionals who conduct audits and inspections of facilities, processes, and documentation to ensure compliance with the U.S. Food and Drug Administration (FDA) regulations, but they do so virtually rather than on site. Using digital tools and secure platforms, they review records, interview staff, and assess procedures from a remote location. This approach increases flexibility and efficiency while maintaining the integrity of compliance checks. Remote FDA Auditors are especially vital for organizations in the pharmaceutical, biotech, food, and medical device industries that must adhere to FDA standards.

What are the key skills and qualifications needed to thrive as a Remote FDA Auditor, and why are they important?

To thrive as a Remote FDA Auditor, you need a deep understanding of FDA regulations, auditing procedures, and quality management systems, typically supported by a degree in life sciences or a related field. Familiarity with electronic audit management tools, documentation systems, and relevant certifications such as Certified Quality Auditor (CQA) are highly valuable. Strong attention to detail, analytical thinking, and effective virtual communication are crucial soft skills for this role. These competencies ensure accurate compliance assessments, clear reporting, and effective collaboration while working remotely.
More about Remote Fda Auditor jobs
What cities are hiring for Remote Fda Auditor jobs? Cities with the most Remote Fda Auditor job openings:
What are the most commonly searched types of Fda Auditor jobs? The most popular types of Fda Auditor jobs are:
What states have the most Remote Fda Auditor jobs? States with the most job openings for Remote Fda Auditor jobs include:
What job categories do people searching Remote Fda Auditor jobs look for? The top searched job categories for Remote Fda Auditor jobs are:
Remote Fda Auditor jobs near you
Infographic showing various Remote Fda Auditor job openings in the United States as of May 2026, with employment types broken down into 4% Internship, 76% Full Time, 9% Part Time, 7% Temporary, 2% Contract, and 2% Nights. Highlights an 87% Physical, 6% Hybrid, and 7% Remote job distribution, with an average salary of $76,256 per year, or $36.7 per hour.

FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM

Manhattan, NY • Remote

Full-time

Posted 9 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.