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Fda Reviewer Jobs (NOW HIRING)

Integrated Resources INC

NJ

FDA guidance, ICH, 21 CFR etc) Review labels as per FDA guidance Regulatory support in drug listing. Perform other duties as assigned Qualifications QUALIFICATIONS BS or MS degree in a scientific ...

CEDENT

Data Reviewer, Quality Control

Verona, WI

The Data Reviewer is responsible for ensuring the completion, quality, and compliance of laboratory ... FDA guidance documents. * Strong verbal and written communication skills and ability to work with ...

Hitachi, Ltd.

FDA Validation Engineer

Nashville, TN · On-site

Join us as an FDA Validation Engineer. Location type: This is an onsite position based in Nashville ... Review qualification/requalification packages for completeness and accuracy, sound rationale ...

Hitachi

FDA Validation Engineer

Nashville, TN · On-site

Join us as an FDA Validation Engineer. Location type: This is an onsite position based in Nashville ... Review qualification/requalification packages for completeness and accuracy, sound rationale ...

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How much do fda reviewer jobs pay per hour?

As of May 29, 2026, the average hourly pay for fda reviewer in the United States is $29.88, according to ZipRecruiter salary data. Most workers in this role earn between $22.60 and $36.54 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an FDA Reviewer, and why are they important?

To thrive as an FDA Reviewer, you need a strong background in scientific research, regulatory affairs, and a relevant advanced degree such as pharmacy, biology, chemistry, or medicine. Familiarity with regulatory submission systems, data analysis tools, and knowledge of FDA guidelines and Good Clinical Practice (GCP) is critical. Attention to detail, effective communication, and critical thinking are essential soft skills for evaluating complex data and collaborating with stakeholders. These skills ensure accurate and thorough assessments of products, supporting public health and regulatory compliance.

What are some common challenges faced by FDA Reviewers during the product evaluation process?

FDA Reviewers often face tight deadlines and must carefully balance thorough scientific evaluation with regulatory timelines. Reviewing large volumes of complex data, ensuring compliance with evolving regulations, and collaborating with multidisciplinary teams can be demanding. Additionally, reviewers must stay updated on new scientific developments and technologies, which requires continual learning and adaptability. These challenges make strong organizational skills and effective communication crucial for success in this role.

What are FDA Reviewers?

FDA Reviewers are professionals who evaluate and assess applications for the approval of drugs, medical devices, biologics, and other products regulated by the U.S. Food and Drug Administration (FDA). They review scientific data, clinical trial results, and manufacturing information to ensure the safety, efficacy, and quality of products before they reach the market. FDA Reviewers work within specialized teams and often collaborate with scientists, physicians, and regulatory experts. Their work helps protect public health by ensuring that only safe and effective products are available to consumers.

What is the difference between Fda Reviewer vs Fda Investigator?

AspectFda ReviewerFda Investigator
Primary RoleReview and evaluate regulatory submissions for safety, efficacy, and compliance of medical productsConduct inspections and investigations to ensure compliance with FDA regulations
Work EnvironmentOffice-based, reviewing documents and dataFieldwork, inspecting facilities and conducting interviews
Required CredentialsTypically a background in life sciences, healthcare, or related fields; often requires a degree and regulatory knowledgeSimilar credentials; often a degree in sciences, with training in inspection procedures

While both roles work within the FDA and require scientific knowledge, Fda Reviewers focus on evaluating submissions for approval, whereas Fda Investigators conduct on-site inspections to verify compliance. Both positions are essential for ensuring the safety and efficacy of medical products, but they differ in daily tasks and work settings.

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Fda Reviewer jobs near you

FDA Consultant (ISO 13485 & ISO 22716 Experience)

IMSM

Manhattan, NY • On-site

Contractor

Posted 29 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

Apply