ZipRecruiter

Log In

1

Fda Jobs in Bothell, WA (NOW HIRING)

SystImmune, Inc

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management * Lead internal audits and inspection readiness for CLIA/CAP and ...

Systimmune

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management * Lead internal audits and inspection readiness for CLIA/CAP and ...

next page

Showing results 1-20

All JobsFda JobsFda Jobs in Bothell, WA

Fda information

Is it hard to get hired by the FDA?

Getting hired by the FDA can be competitive due to the specialized nature of the roles and the high standards for education, experience, and security clearances. Candidates often need relevant degrees, such as in science or public health, and may undergo rigorous screening and interviews. Strong technical skills and knowledge of regulatory processes improve chances of employment.

How much do you make working for FDA?

Salaries for FDA employees vary by position, experience, and location, but the average annual salary ranges from approximately $50,000 for entry-level roles to over $150,000 for senior scientists and management positions. Federal pay scales and certifications can influence compensation, and many roles include benefits such as health insurance and retirement plans.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What are the key skills and qualifications needed to thrive as an FDA (U.S. Food and Drug Administration) Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What does an FDA (Food and Drug Administration) professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

Does FDA have remote jobs?

The FDA offers some remote job opportunities, particularly in roles related to policy, research, and administrative support. However, many positions require on-site presence at FDA facilities or laboratories, and remote work availability depends on the specific role and department. Candidates should review individual job postings for remote work options and requirements.

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, which can have salaries exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and often involve overseeing regulatory policies and organizational management.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What are popular job titles related to Fda jobs in Bothell, WA? For Fda jobs in Bothell, WA, the most frequently searched job titles are:
What job categories do people searching Fda jobs in Bothell, WA look for? The top searched job categories for Fda jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Fda jobs? Cities near Bothell, WA with the most Fda job openings:
Fda jobs near you
Infographic showing various Fda job openings in Bothell, WA as of July 2026, with employment types broken down into 67% Full Time, 11% Part Time, and 22% Contract. Highlights an 100% In-person job distribution.
Senior CAPA FDA Lead

Senior CAPA FDA Lead

Accord Technologies Inc.

Bothell, WA • On-site

Contractor

Re-posted 4 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