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Fda Reviewer Jobs (NOW HIRING)

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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 ...

Real Soft, Inc.

Regulatory Affairs contractor

$100/hr

FDA 510(k) submission * Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality ...

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

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 Jun 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 is the highest paying job at the FDA?

The highest paying roles at the FDA are typically senior leadership positions such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These roles often require extensive experience, advanced degrees, and leadership skills, and may include additional benefits and bonuses.

Is it hard to get a job at FDA?

Becoming an FDA reviewer can be competitive due to the specialized knowledge required in areas like regulatory science, biostatistics, or clinical research. Candidates typically need relevant education, experience, and often pass a federal hiring process that includes assessments and background checks.

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.

How much do FDA workers get paid?

FDA reviewers are federal employees whose salaries are determined by the General Schedule (GS) pay scale. Entry-level FDA reviewers typically start at GS-7 or GS-9, with salaries ranging from approximately $50,000 to $70,000 annually, and can increase with experience and seniority. Many FDA reviewers also receive benefits such as health insurance and retirement plans.

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.

How do you become a FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in regulatory or quality assurance roles. They must pass the FDA's specialized training program and often undergo background checks; some positions require a background in science or public health and familiarity with inspection tools and procedures.

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.

More about Fda Reviewer jobs
What cities are hiring for Fda Reviewer jobs? Cities with the most Fda Reviewer job openings:
What states have the most Fda Reviewer jobs? States with the most job openings for Fda Reviewer jobs include:
What job categories do people searching Fda Reviewer jobs look for? The top searched job categories for Fda Reviewer jobs are:
Fda Reviewer jobs near you
Infographic showing various Fda Reviewer job openings in the United States as of June 2026, with employment types broken down into 33% Part Time, and 67% Contract. Highlights an 100% In-person job distribution, with an average salary of $62,159 per year, or $29.9 per hour.

Regulatory Specialist

Trinite Consulting Group LLC

Rosemont, IL • On-site

Other

Posted 7 days ago

Job description

Description: 

Key Responsibilities:

1. Provide strategic input and technical guidance on regulatory requirements to R&D project teams. 

2. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. 3. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high quality submissions. 

4. Monitor product-related activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices. 5. Review all supporting documentation required in regulatory applications for accuracy and completeness and determine the applicability of supporting documentation for inclusion in regulatory submission. 

6. Keep abreast of additions, changes, and emerging trends to regulations and guidelines and evaluate relevance to company and products.

 7. Provide the regulatory perspective on Due Diligence activities in support of potential new business opportunities. Review data/information as needed. 

8. Be familiar with Global regulatory aspects of all the global products; contribute to discussions and regulatory strategies as needed. 9. Establish expertise on guidelines and regulatory requirements for combination products. 

10. Ensure the maintenance of FDA Controlled Correspondences log in an easily searchable format to enable quick reference to resolved issues. 

11. Ensure the maintenance of FDA Information Requests log for A/NDAs in an easily searchable format to provide insight into FDA review trends.

 12. Review and oversee the development and/or revision of Standard Operation Procedures as they relate to cGMP quality and regulatory compliance. 

Required Education and Experience: 

  •  BS/BA required in a scientific discipline. 
  •  Minimum of 12 years of experience in the pharmaceutical/biotech industry within the Regulatory Affairs/R&D functions. 
  •  Deep and broad knowledge of regulatory affairs. 
  •  Direct, hands-on experience with pharmaceutical regulatory submissions and product • approvals.
  •  Experience with post-approval life cycle management of marketed products. 
  •  Proven track record of effective collaboration with regulatory agencies, including the FDA 
  •  Solid knowledge of cGMP regulations and current industry trends related to pharmaceutical and biological products. 
  •  Thorough understanding of the applicable sections of the US Code of Federal Regulations, FDA/ICH guidelines and cGMP''s, as they pertain to pharmaceuticals. 
  •  Advanced degree in a scientific discipline preferred 
  •  Must be able to serve as the company expert on regulatory affairs.
  •   Strong entrepreneurial abilities, sense of urgency, and team player. 
  •  Well-developed organizational, interpersonal, and project management skills. 
  •  Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions. 
  •  Experience with combination products. 
  •  Excellent written and verbal communication required.
  •  Must be willing to travel.

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