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Fda Auditor Jobs (NOW HIRING)

ResMed, Inc.

Quality Auditor

San Diego, CA · On-site

This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States ... Also, the role will be responsible for all aspects of auditing to ensure regulation compliance ...

Boston Scientific

Senior QA Auditor

Valencia, CA · On-site

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Boston Scientific

Senior QA Auditor

Valencia, CA · On-site

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Boston Scientific

Senior QA Auditor

Santa Clarita, CA · On-site

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Teleflex

Quality Auditor

Morrisville, NC · On-site

Position Summary Teleflex is seeking a Quality Auditor to join our Strategic Compliance department ... FDA Title 21 CFR 820 QMSR ISO 13485:2016 Desired: MHLW No. 169; Ministerial Ordinance SOR 98-282;

Ferrero

Packaging FSQ Auditor

Chicago, IL · Hybrid

$96K - $154K/yr

Business Experience: 8+ years of Packaging experience Direct experience with Packaging regulations in North America (FDA & CFIA) Experience in leading packaging audits (auditor certification ...

Teleflex

Quality Auditor

Morrisville, NC · On-site

Position Summary Teleflex is seeking a Quality Auditor to join our Strategic Compliance department ... Required: • FDA Title 21 CFR 820 QMSR • ISO 13485:2016 Desired: • MHLW No. 169; Ministerial ...

Online Labels

Quality Control Auditor

Sanford, FL · On-site

$17 - $20/hr

Knowledge of Quality Management Systems (ISO,FDA, BSI) is preferred. * Knowledge of Flexographic and/or digital printing or previous experience as a Quality Auditor is preferred. Pay: $17.00-20.00 ...

New

Online Labels Group

Quality Control Auditor

Sanford, FL · On-site

$17 - $20/hr

Knowledge of Quality Management Systems (ISO,FDA, BSI) is preferred. * Knowledge of Flexographic and/or digital printing or previous experience as a Quality Auditor is preferred. Pay: $17.00-20.00 ...

New

Ferrero

Packaging FSQ Auditor

Chicago, IL · On-site

$96K - $154K/yr

Business Experience: • 8+ years of Packaging experience • Direct experience with Packaging regulations in North America (FDA & CFIA) • Experience in leading packaging audits (auditor ...

Ferrero

Packaging FSQ Auditor

Chicago, IL · Hybrid

$96K - $154K/yr

Business Experience: • 8+ years of Packaging experience • Direct experience with Packaging regulations in North America (FDA & CFIA) • Experience in leading packaging audits (auditor ...

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All JobsFda Auditor Jobs

Fda Auditor information

See salary details

$33K

$76.3K

$121.5K

How much do fda auditor jobs pay per year?

As of Jul 15, 2026, the average yearly pay for 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.

How much does an FDA auditor get paid?

An FDA auditor's salary typically ranges from $60,000 to $100,000 annually, depending on experience, location, and employer. Senior auditors or those with specialized certifications may earn higher wages, and the role often requires knowledge of regulatory standards and inspection procedures.

What is an FDA Auditor job?

An FDA Auditor is responsible for inspecting facilities, processes, and documentation to ensure compliance with U.S. Food and Drug Administration (FDA) regulations. They review manufacturing practices, quality control systems, and regulatory filings for industries such as pharmaceuticals, medical devices, and food production. FDA Auditors may work for the FDA or for companies preparing for FDA inspections. Their role helps ensure public safety by verifying that products meet legal and quality standards.

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, as well as senior scientific and regulatory positions like Directors or Chief Scientists. These roles often require advanced degrees, extensive experience, and specialized expertise, and they can earn salaries exceeding $200,000 annually, including bonuses and benefits.

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

To thrive as an FDA Auditor, you need a strong background in life sciences, regulatory compliance, and audit methodologies, usually supported by a relevant degree and professional certifications such as RAC or CQA. Familiarity with FDA regulations (such as 21 CFR), electronic quality management systems (eQMS), and audit management tools is essential. Attention to detail, critical thinking, and strong communication skills help auditors navigate complex regulatory settings and interact effectively with stakeholders. These competencies are crucial for ensuring companies meet rigorous FDA standards and maintain regulatory compliance.

Is it hard to get hired by the FDA?

Getting hired as an FDA auditor can be competitive due to the specialized skills and qualifications required, such as a background in science, healthcare, or regulatory affairs, along with relevant certifications. Candidates often need experience in quality assurance, compliance, or inspection roles, and the hiring process may involve multiple interviews and background checks.

How do you become an FDA auditor?

To become an FDA auditor, candidates typically need a background in life sciences, healthcare, or quality assurance, along with experience in regulatory compliance or manufacturing. Earning certifications such as Certified Quality Auditor (CQA) or attending FDA-specific training programs can enhance qualifications. Auditors often need to understand FDA regulations, Good Manufacturing Practices (GMP), and have strong inspection skills.

What are the primary challenges FDA Auditors face during compliance inspections?

FDA Auditors often encounter challenges such as interpreting complex and evolving regulatory guidelines, managing on-site audits in diverse environments, and reviewing extensive documentation under tight timeframes. They must adapt quickly to various industry settings, handle potentially uncooperative stakeholders, and maintain objectivity throughout their evaluations. Successfully overcoming these challenges requires resilience, up-to-date regulatory knowledge, and excellent people skills. These hurdles are a vital part of ensuring public health and safety by holding organizations to the highest standards of compliance.

More about Fda Auditor jobs
What cities are hiring for Fda Auditor jobs? Cities with the most 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 Fda Auditor jobs? States with the most job openings for Fda Auditor jobs include:
What job categories do people searching Fda Auditor jobs look for? The top searched job categories for Fda Auditor jobs are:
Fda Auditor jobs near you
Infographic showing various Fda Auditor job openings in the United States as of July 2026, with employment types broken down into 88% Full Time, 6% Part Time, and 6% Nights. Highlights an 100% In-person 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 • On-site

Contractor

This job post has expired today. Applications are no longer accepted.

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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