Top 93 Regulatory affairs lead Jobs in Bothell Wa

Director, Quality Systems – IVD / Companion Diagnostic
Yoh, A Day & Zimmermann Company —Redmond, WA
- $180,000 - $230,000 a year
- Full-time
- 5 years
- Product management
- Contracts
- Health savings account
- Disability insurance
Quick Apply
11d
Regulatory Affairs Consultant, In Silico Modeling
Pharmatech Associates —Seattle, WA
- Part-time
- Remote
- Senior level
- Leadership
- 10 years
Regulatory Affairs Associate II
INBIOS INTERNATIONAL INC —Seattle, WA
- $91,500 - $125,000 a year
- Full-time
- Mid-level
- Microsoft Office
- Master's degree
- Paid holidays
- Disability insurance
Quick Apply
Homelessness and Housing Policy Lead Advisor
King County —Seattle, WA
- $146,331.12 - $185,482.96 a year
- Hybrid work
- Writing skills
- Office
- 8 years
- Paid holidays
- Disability insurance
1d
Regulatory Affairs Operations Manager
University of Washington —Seattle, WA
- $120,000 - $174,000 a year
- Full-time
- Nursing
- 6 years
- Bachelor of Science
Associate Dean of Equity and Student Engagement
Renton Technical College —Renton, WA
- $120,527.58 - $125,527.58 a year
- 8 hour shift
- Background check
- Writing skills
- Office
- AD&D insurance
- Paid holidays
HAWP Quality and Compliance Analyst
International Community Health Services —Seattle, WA
- $33.58 - $49.16 an hour
- Full-time
- Nursing
- HIPAA
- Mid-level
- Wellness program
- Paid holidays
Quick Apply
Associate Director of Student Engagement
Bellevue College —Bellevue, WA
- $72,488 - $101,483 a year
- Overtime
- Background check
- Inventory management
- Mid-level
- Paid holidays
- Disability insurance
Senior Manager, Quality Operations (Onsite)
Stryker —Redmond, WA
- $155,900 - $259,800 a year
- Full-time
- Oracle
- Engineering
- Recruiting
- Health savings account
- AD&D insurance
Senior Energy Program Manager - Communications & Regulatory
Puget Sound Energy —Bellevue, WA
- $108,200 - $180,200 a year
- Pass drug screening
- 8 years
- Accounting
- AD&D insurance
- Paid holidays
9d
Chief Product Officer
Grüns —Seattle, WA
- $350,000 a year
- Remote
- 11+ years
- Senior level
- Leadership
- Paid time off
Quick Apply
Regional Director (Pacific Northwest)
CLEAR - Field —Seattle, WA
- $170,000 - $220,000 a year
- Bachelor's degree
- Travel
- Mentoring
- Paid parental leave
- Paid holidays
Quick Apply
Commercialization Lead
Endurance Energy —Seattle, WA
- $200,000 - $250,000 a year
- Full-time
- 7 years
- Travel
- Contracts
- Paid holidays
- Health insurance
Senior Director, Global Regulatory Lead
Immunome, Inc. —Seattle, WA
- $226,000 - $270,000 a year
- Bachelor's degree
- Mentoring
- Senior level
Quick Apply
Director of Environmental Affairs
NorthStar Energy Shared Services —Seattle, WA
- $156,175 - $234,262 a year
- Full-time
- Engineering
- 11+ years
- Travel
- AD&D insurance
- Disability insurance
Program Operations Specialist - Credentialing - School of Medicine, Office of Medical Staff Affairs
University of Washington —Seattle, WA
- $61,368 - $92,064 a year
- Full-time
- Management
- Bachelor's degree
- Organizational skills
9d
Business Program Manager Lead, Legal Operations
Microsoft —Redmond, WA
- $130,900 - $303,600 a year
- Full-time
- 6 years
- Finance
- Bachelor's degree
3d
Communications Specialist, Amazon Leo
Amazon.com Services LLC —Seattle, WA
- $82,700 - $134,000 a year
- Full-time
- Bachelor's degree
- Senior level
- AD&D insurance
- Health insurance
Sr. Manager, Communications — Strategic Narrative & Market Intelligence
T-Mobile USA, Inc. —Bellevue, WA
- $115,100 - $249,120 a year
- Full-time
- Hybrid work
- 18 years or older
- 7 years
- Management
- Paid parental leave
- AD&D insurance
10d
Dean of Enrollment & Access
Shoreline Community College —Shoreline, WA
- $130 an hour
- Online Application
- Bilingual
- Background check
- Microsoft Excel
- AD&D insurance
- Disability insurance

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Director, Quality Systems – IVD / Companion Diagnostic

Yoh, A Day & Zimmermann Company -
Redmond, WA

Quick Apply

Job Details

Full-time
$180,000 - $230,000 a year
11 days ago

Benefits

Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Employee assistance program
Vision insurance
Referral program

Qualifications

Quality control corrective actions
FDA submissions
Regulatory inspections
Contract management
Stakeholder engagement
Preventive action implementation
Corrective and preventive actions (CAPA)
Supplier audits
Vendor compliance management
Quality risk management
Quality control documentation
Compliance documentation
Contracts
Regulatory/legal compliance standards in production
Design controls
Biomedical regulatory compliance
Regulatory submissions
ISO 13485
Stakeholder relationship building
Cross-functional communication
Supplier quality assurance (SQA)
Stakeholder management

Full Job Description

We are seeking an experienced Director, Quality Systems – IVD / Companion Diagnostics to join a growing clinical-stage biotechnology organization advancing oncology and precision-medicine programs.

This individual will play a key role in building, leading, and continuously improving the Quality Management System supporting regulated diagnostic programs from development through validation, regulatory submission, and commercialization. This is a hands-on leadership position for someone who understands the intersection of quality systems, diagnostic product development, design controls, and regulatory compliance.

The ideal candidate has direct experience within IVD, companion diagnostics, or regulated medical devices and is comfortable establishing scalable quality processes while partnering closely with scientific, regulatory, clinical, and external development teams.

Location: Greater Seattle Area, WA (onsite)
Type: Full Time
Compensation: Base salary $180,000–$230,000 (DOE)
Industry: Biotechnology / IVD / Companion Diagnostics

What You’ll Do:

Lead and continuously improve the Quality Management System supporting regulated diagnostic and companion diagnostic programs
Ensure compliance with applicable requirements including 21 CFR Part 820, ISO 13485, and ISO 14971
Provide Quality leadership across diagnostic development, validation, transfer, regulatory submission, and commercialization activities
Establish and oversee design controls, including design inputs/outputs, verification, validation, design reviews, traceability, and design transfer
Integrate risk-management principles throughout the diagnostic product lifecycle
Lead CAPA, deviations, nonconformances, investigations, change control, and document-control activities
Develop and maintain SOPs, quality policies, and controlled documentation
Oversee qualification and ongoing monitoring of critical suppliers, CROs, contract laboratories, manufacturing partners, and diagnostic platform vendors
Establish and manage quality agreements and supplier-performance expectations
Support internal audits, external audits, regulatory inspections, and overall inspection readiness
Serve as a key Quality representative during FDA, ISO, partner, and regulatory interactions
Partner closely with R&D, Regulatory Affairs, Clinical, Pathology, Operations, and external diagnostic partners
Help build scalable Quality processes and capabilities as programs advance

What We’re Looking For:

Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred
10+ years of Quality experience within IVD, companion diagnostics, medical devices, or another closely regulated diagnostics environment
5+ years of progressive Quality leadership experience
Strong hands-on knowledge of 21 CFR Part 820 and ISO 13485
Working knowledge of ISO 14971 and product risk management
Demonstrated experience with design controls and regulated product-development lifecycles
Strong experience with CAPA, investigations, deviations, change control, and document control
Experience with supplier quality, quality agreements, audits, and external partner oversight
Experience supporting FDA inspections and/or ISO audits
Ability to operate both strategically and hands-on in a growing organization
Strong cross-functional communication and stakeholder-management skills

Nice to Have:

Direct experience with companion diagnostics (CDx)
Experience with IHC, pathology, or biomarker-based diagnostic programs
Experience transitioning assays from early development into regulated commercial diagnostic products
Experience supporting late-stage or commercial IVD/CDx programs
Background working with diagnostic platform providers, reagent suppliers, CROs, central laboratories, or contract manufacturers
Experience helping establish or significantly improve a QMS within a growing organization

Work Environment:

Collaborative, science-driven biotechnology environment
High-visibility role with significant ownership of Quality strategy and execution
Close partnership with scientific, regulatory, clinical, and external development teams
Hands-on leadership position within a growing diagnostic organization
Full-time onsite position in the Greater Seattle area

#IND-SPG

Estimated Min Rate: $180,000
Estimated Max Rate: $230,000

What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
Health Savings Account (HSA) (for employees working 20+ hours per week)
Life & Disability Insurance (for employees working 20+ hours per week)
MetLife Voluntary Benefits
Employee Assistance Program (EAP)
401K Retirement Savings Plan
Direct Deposit & weekly epayroll
Referral Bonus Programs
Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice

Stay Safe During Your Job Search
Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information.
IND-SPG

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Refine Your Search

regulatory affairs lead jobs in bothell wa

Director, Quality Systems – IVD / Companion Diagnostic

Regulatory Affairs Consultant, In Silico Modeling

Regulatory Affairs Associate II

Homelessness and Housing Policy Lead Advisor

Regulatory Affairs Operations Manager

Associate Dean of Equity and Student Engagement

HAWP Quality and Compliance Analyst

Associate Director of Student Engagement

Senior Manager, Quality Operations (Onsite)

Senior Energy Program Manager - Communications & Regulatory

Chief Product Officer

Regional Director (Pacific Northwest)

Commercialization Lead

Senior Director, Global Regulatory Lead

Director of Environmental Affairs

Program Operations Specialist - Credentialing - School of Medicine, Office of Medical Staff Affairs

Business Program Manager Lead, Legal Operations

Communications Specialist, Amazon Leo

Sr. Manager, Communications — Strategic Narrative & Market Intelligence

Dean of Enrollment & Access

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