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Fda Reviewer Jobs in Seattle, WA (NOW HIRING)

Jobtailor

Director, Pharmacovigilance

Seattle, WA · On-site

$110 - $180/hr

Oversee case processing activities, including intake, triage, medical review support, and expedited reporting * Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)

Verathon, Inc.

Manager, Regulatory Affairs

Bothell, WA · On-site

This manager serves as the primary regulatory owner for FDA 510(k) submissions and global registration activities, providing strategic oversight, technical review, and team development. This role ...

Verathon, Inc.

Manager, Regulatory Affairs

Bothell, WA · On-site

$116.58 - $163.57/hr

This manager serves as the primary regulatory owner for FDA 510(k) submissions and global registration activities, providing strategic oversight, technical review, and team development. This role ...

International Recruiting LLC

Clinical Medicine

Bellevue, WA

$20.25 - $25.75/hr

Support SAE review, safety narratives, aggregate safety assessments, unblinding procedures, and FDA safety reporting. * Participate in protocol development, investigator meetings, site training ...

Fortive

Quality Engineer

Everett, WA

$79K - $102K/yr

External : Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers ... Handle Complaints, Non-Conformances, Corrective/Preventive Actions, and Material Review Board ...

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All JobsFda Reviewer JobsFda Reviewer Jobs in Seattle, WA

Fda Reviewer information

See Seattle, WA salary details

$12

$34

$55

How much do fda reviewer jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for fda reviewer in Seattle, WA is $34.03, according to ZipRecruiter salary data. Most workers in this role earn between $25.72 and $41.59 per hour, depending on experience, location, and employer.

What is an FDA reviewer?

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 skills and qualifications are needed to be an FDA reviewer?

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 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 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.

How much do FDA reviewers make?

FDA reviewers typically earn a salary ranging from $70,000 to $130,000 annually, depending on experience, education, and location. They often hold degrees in science or healthcare and work in regulatory environments that require attention to detail and knowledge of FDA regulations.

What are popular job titles related to Fda Reviewer jobs in Seattle, WA?

For Fda Reviewer jobs in Seattle, WA, the most frequently searched job titles are:

What job categories do people searching Fda Reviewer jobs in Seattle, WA look for?

The top searched job categories for Fda Reviewer jobs in Seattle, WA are:

Fda Reviewer jobs near you
Infographic showing various Fda Reviewer job openings in Seattle, WA as of August 2026, with employment types broken down into 80% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $70,779 per year, or $34 per hour.

Senior CAPA FDA Lead

Accord Technologies Inc.

Bothell, WA • On-site

Contractor

Re-posted 11 days ago

Job description

Position : Senior CAPA FDA Lead
Location: Bothell, Washington
Visa: Any Visa
Position type: C2C

 
 
Job Description

Key Responsibilities
  • Lead FDA audit and inspection readiness activities across the business.
  • Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions.
  • Act as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
  • Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
  • Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
  • Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
  • Conduct gap assessments against FDA expectations and industry best practices.
  • Support mock audits, inspection simulations, and response preparation activities.
  • Ensure timely closure of audit observations, commitments, and remediation plans.
  • Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
  • Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.
     
Required Experience
  • 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
  • Strong hands-on experience in:
    • CAPA management systems
    • Root cause investigations
    • Health Hazard Evaluation (HHE)
    • FDA audit/inspection management
    • Regulatory compliance programs
  • Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
  • Demonstrated experience handling regulatory escalations, observations, and remediation programs.
  • Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
  • Experience working in cross-functional and high-pressure audit environments.
Preferred Qualifications
  • Experience handling FDA inspections involving critical observations or remediation programs.
  • Exposure to recalls, field actions, complaint handling, and product risk evaluations.
  • Certifications in Quality or Regulatory disciplines are preferred.
  • Strong executive communication and stakeholder management skills.
     
Key Skills
  • FDA Inspection Readiness
  • CAPA Effectiveness
  • Health Hazard Evaluation (HHE)
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Audit Presentation & Defense
  • Quality Systems
  • Cross-functional Leadership
  • Executive Communication
Location: Bothell, Washington
Visa: Any Visa
Position type: C2C Contract

Job Title
Senior CAPA FDA Lead
Job Description
Key Responsibilities
  • Lead FDA audit and inspection readiness activities across the business.
  • Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions.
  • Act as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
  • Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
  • Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
  • Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
  • Conduct gap assessments against FDA expectations and industry best practices.
  • Support mock audits, inspection simulations, and response preparation activities.
  • Ensure timely closure of audit observations, commitments, and remediation plans.
  • Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
  • Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.
     
Required Experience
  • 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
  • Strong hands-on experience in:
    • CAPA management systems
    • Root cause investigations
    • Health Hazard Evaluation (HHE)
    • FDA audit/inspection management
    • Regulatory compliance programs
  • Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
  • Demonstrated experience handling regulatory escalations, observations, and remediation programs.
  • Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
  • Experience working in cross-functional and high-pressure audit environments.
Preferred Qualifications
  • Experience handling FDA inspections involving critical observations or remediation programs.
  • Exposure to recalls, field actions, complaint handling, and product risk evaluations.
  • Certifications in Quality or Regulatory disciplines are preferred.
  • Strong executive communication and stakeholder management skills.
     
Key Skills
  • FDA Inspection Readiness
  • CAPA Effectiveness
  • Health Hazard Evaluation (HHE)
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Audit Presentation & Defense
  • Quality Systems
  • Cross-functional Leadership
  • Executive Communication