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Fda Inspector Jobs in Bothell, WA (NOW HIRING)

Albertsons

Quality Assurance Manager

Bellevue, WA · On-site

Serve as primary contact for State, FDA, third-party, and customer audits; lead inspections, responses, and corrective action closure. * Product Safety Authority: Make final decisions on product ...

Albertsons

Quality Assurance Manager

Bellevue, WA

$120K - $138K/yr

Serve as primary contact for State, FDA, third-party, and customer audits; lead inspections, responses, and corrective action closure. * Product Safety Authority: Make final decisions on product ...

Albertsons

Quality Assurance Manager

Bellevue, WA · On-site

Serve as primary contact for State, FDA, third-party, and customer audits; lead inspections, responses, and corrective action closure. * Product Safety Authority: Make final decisions on product ...

ELITechGroup Inc.

Quality Assurance Associate

Bothell, WA · On-site

$30 - $32/hr

Performs finished product inspection. * Performs review and approval of labels. * Reviews SPEC ... Participates during audits (FDA, ISO, vendor) * Assists Document Control, (assign CC and document ...

Lincare

Delivery Driver - Medical Equipment

Bremerton, WA · On-site

$17.13 - $23/hr

Inspect and maintain company-provided delivery vehicle, ensuring safety during the loading and ... Maintain cleanliness and organization of delivery vehicle and warehouse, adhering to all FDA ...

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All JobsFda Inspector JobsFda Inspector Jobs in Bothell, WA

Fda Inspector information

See Bothell, WA salary details

$27.4K

$61.4K

$110.7K

How much do fda inspector jobs pay per year?

As of Jul 22, 2026, the average yearly pay for fda inspector in Bothell, WA is $61,416.00, according to ZipRecruiter salary data. Most workers in this role earn between $43,000.00 and $71,000.00 per year, depending on experience, location, and employer.

How much do FDA drug investigators make?

FDA drug investigators typically earn a salary ranging from $70,000 to $120,000 annually, depending on experience, location, and level of responsibility. They often hold a bachelor's degree in a relevant field and may require specialized training or certifications related to regulatory compliance and inspection procedures.

What types of facilities or products do FDA Inspectors typically review, and what does a typical inspection process involve?

FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.

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

To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.

What type of inspector gets paid the most?

Among FDA inspectors, senior or specialized inspectors, such as those overseeing complex manufacturing facilities or with advanced certifications, tend to earn higher salaries. Experience, certifications, and geographic location also influence pay levels for FDA inspectors. Generally, inspectors with specialized skills or leadership roles earn the most in this field.

Is it hard to get a job at FDA?

Becoming an FDA inspector can be competitive due to strict qualification requirements, including relevant experience, education, and passing civil service exams. Candidates often need a background in science, public health, or regulatory compliance, along with strong attention to detail and communication skills. The hiring process can be lengthy and involves multiple steps such as interviews and background checks.

How do you become an 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 food safety, pharmaceuticals, or manufacturing. They must pass a written exam and a background check, and often complete on-the-job training or specialized FDA training programs. Certification or licensing is not required but can enhance prospects.

What does an FDA Inspector do?

An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.

What job categories do people searching Fda Inspector jobs in Bothell, WA look for? The top searched job categories for Fda Inspector jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Fda Inspector jobs? Cities near Bothell, WA with the most Fda Inspector job openings:
Fda Inspector jobs near you
Infographic showing various Fda Inspector job openings in Bothell, WA as of June 2026, with employment types broken down into 72% Full Time, 14% Part Time, 13% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $61,416 per year, or $29.5 per hour.
Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)

Associate Director / Director, Regulatory Affairs - IHC Companion Diagnostics (CDx)

SystImmune, Inc

Redmond, WA • On-site

$150K - $230K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 20 days ago

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline. This role will serve as the regulatory authority for CDx programs, with direct FDA CDRH engagement, and will build and lead a growing CDx Regulatory team over time.
The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining sufficiently hands-on to provide technical oversight and mentorship when needed. This position reports directly to the Head of CDx and is a core leadership role in the CDx organization.
Key Responsibilities
CDx Regulatory Leadership
  • Lead US regulatory strategy for IHC-based Companion Diagnostics across multiple oncology programs
  • Serve as the regulatory decision-maker for CDx development, submissions, and FDA engagement
  • Establish CDx regulatory best practices, processes, and governance within the organization
FDA CDRH Engagement & Representation
  • Act as the senior regulatory representative to FDA CDRH for IHC CDx programs
  • Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions at a strategic and executional level
  • Guide preparation of FDA briefing packages and responses, ensuring scientific and regulatory consistency
Team Building & People Leadership
  • Build, mentor, and lead a CDx Regulatory Affairs team, with direct reports added over time
  • Set expectations, review work quality, and develop regulatory talent within the CDx organization
  • Provide regulatory leadership and mentorship to cross-functional partners and junior team members
Cross-Functional & External Leadership
  • Partner with Drug Regulatory (CDER), Clinical Development, Biomarker, Pathology, and QA leaders to ensure aligned drug-diagnostic co-development
  • Lead regulatory coordination with external diagnostic partners, CROs, and central laboratories
  • Represent CDx Regulatory perspectives in senior cross-functional and program governance meetings
Submission Oversight & Quality
  • Provide leadership oversight for IDE, PMA, and PMA supplement submissions for IHC CDx
  • Ensure analytical and clinical performance strategies (including scoring and cutoff rationale) meet FDA expectations
  • Maintain high regulatory quality standards while enabling efficient execution
Risk Management & Readiness
  • Identify and proactively manage regulatory risks related to IHC assay performance, interpretation, and transfer
  • Support inspection readiness and regulatory compliance for CDx partners and internal processes
  • Monitor evolving FDA CDx and IHC-related guidance and assess impact on portfolio strategy

Qualifications
  • Bachelor's degree or higher in Life Sciences, Pathology, Molecular Biology, or related field
  • 8+ years (Associate Director) or 10+ years (Director) of regulatory affairs experience in IVD/CDx
  • Demonstrated experience leading FDA CDRH interactions for Companion Diagnostics
  • Strong background in IHC-based CDx development, including understanding of scoring systems and clinical cutoffs
  • Proven ability to lead cross-functional teams and influence without authority

Preferred
  • Prior experience managing or building regulatory teams
  • Oncology CDx experience supporting patient selection strategies
  • Experience working with automated IHC platforms and external diagnostic partners
  • Familiarity with global CDx regulations (EU IVDR, China NMPA)

Leadership Competencies
  • Strategic decision-making with execution awareness
  • Clear, confident FDA-facing communication
  • Ability to develop people and build scalable regulatory functions
  • Strong judgment balancing regulatory rigor with program timelines

Compensation and Benefits:
The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Apply