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Director Fda Tobacco Inspector Jobs in Bothell, WA

Doist

Director, Clinical Development Systems

Bothell, WA · On-site

$229 - $256/hr

FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a ... Partner with Quality Assurance on system validation, inspection-readiness, audits and regulatory ...

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Director Fda Tobacco Inspector information

See Bothell, WA salary details

$13

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$58

How much do director fda tobacco inspector jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for director fda tobacco inspector in Bothell, WA is $30.58, according to ZipRecruiter salary data. Most workers in this role earn between $20.67 and $35.19 per hour, depending on experience, location, and employer.

What is the difference between Director Fda Tobacco Inspector vs Tobacco Inspector?

AspectDirector Fda Tobacco InspectorTobacco Inspector
CertificationsFDA certifications, compliance trainingBasic inspection certifications, industry-specific training
Work EnvironmentRegulatory agencies, corporate compliance departmentsManufacturing plants, quality control labs
Employer & IndustryFDA, government agencies, tobacco companiesTobacco manufacturing, quality assurance firms

The main difference is that a Director Fda Tobacco Inspector oversees regulatory compliance at a higher level, often managing teams and policies, while a Tobacco Inspector conducts on-the-ground inspections of tobacco products and facilities. The Director role involves strategic oversight, whereas the Inspector focuses on detailed product and process checks.

How do you become a Director FDA Tobacco Inspector?

To become a Director FDA Tobacco Inspector, candidates typically need a background in public health, regulatory compliance, or law enforcement, along with experience in tobacco product regulation. Advancement often requires progressing through inspector roles, gaining specialized knowledge, and demonstrating leadership skills, with some positions requiring federal employment exams or certifications. Strong analytical, communication, and inspection skills are essential for this role.

What job categories do people searching Director Fda Tobacco Inspector jobs in Bothell, WA look for?

The top searched job categories for Director Fda Tobacco Inspector jobs in Bothell, WA are:

What cities near Bothell, WA are hiring for Director Fda Tobacco Inspector jobs?

Cities near Bothell, WA with the most Director Fda Tobacco Inspector job openings:

Director Fda Tobacco Inspector jobs near you
Infographic showing various Director Fda Tobacco Inspector job openings in Bothell, WA as of August 2026, with employment types broken down into 2% As Needed, 76% Full Time, 18% Part Time, 1% Temporary, and 3% Contract. Highlights an 89% Physical, 5% Hybrid, and 6% Remote job distribution, with an average salary of $63,613 per year, or $30.6 per hour.

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 18 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.

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