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
4d
Regulatory Affairs Specialist II
Seattle Children's Hospital —Seattle, WA
- $80,715 - $121,073 a year
- Master's degree
- Bachelor's degree
- Pediatrics
- Health insurance
- Dental insurance
Manager, Regulatory Affairs
Jade Biosciences —Seattle, WA
- $135,000 - $150,000 a year
- Remote
- Microsoft Word
- 3 years
- Bachelor's degree
Quick Apply
Research Associate I
Omeros Corporation —Seattle, WA
- $65,000 - $85,000 a year
- Email
- Bachelor's degree
- Pediatrics
- Communication skills
- Paid holidays
- Health insurance
Regulatory & External Affairs Analyst
Ziply Fiber —Kirkland, WA
- $70,500 - $98,000 a year
- Background check
- Microsoft Outlook
- Writing skills
- Health insurance
- Dental insurance
Quick Apply
6d
Environmental Compliance Specialist
NORTHSTAR ENERGY LLC —Seattle, WA
- $84,000 - $126,001 a year
- Full-time
- Remote
- Engineering
- Mid-level
- Travel
- Health insurance
- Dental insurance
Manager, Regulatory Affairs
Verathon, Inc. —Bothell, WA
- $116,581 - $163,567 a year
- Full-time
- Hybrid work
- Office
- 3 years
- Travel
- Paid holidays
- Health insurance
3d
Regulatory Coordinator I/II - Lab Based Studies
Fred Hutchinson Cancer Center —Seattle, WA
- $28.36 - $50.12 an hour
- Full-time
- Hybrid work
- Mid-level
- High school diploma or GED
- Associate's degree
- Paid parental leave
- Paid holidays
Regulatory Affairs Consultant, In Silico Modeling
Pharmatech Associates —Seattle, WA
- Part-time
- Senior level
- Leadership
- 10 years
Strategic Researcher
WSNA —Tukwila, WA
- $89,635.10 - $169,738.61 a year
- Full-time
- Microsoft Excel
- Office
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
NODES Research Study Coordinator
Veteran Affairs —Seattle, WA
- $69,000 - $83,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Customer service
- Health insurance
- Dental insurance
Quick Apply
Director, Clinical Research Quality Assurance and Regulatory Support
Seattle Children's Hospital —Seattle, WA
- $180,884 - $271,326 a year
- 7 years
- Master's degree
- Bachelor's degree
- Health insurance
- Dental insurance
Associate Regulatory Counsel, Privacy
Google —Seattle, WA
- $217,000 - $315,000 a year
- Full-time
- Office
- 3 years
- Fair chance
- Paid holidays
- Disability insurance
Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx)
SystImmune —Redmond, WA
- $150,000 - $230,000 a year
- Full-time
- Office
- Bachelor's degree
- Mentoring
- Paid holidays
- Disability insurance
Senior Director, Clinical Regulatory Affairs
Umoja Biopharma —Seattle, WA
- $253,000 - $337,000 a year
- Bachelor of Science
- 11+ years
- Bachelor's degree
- Commuter assistance
- Health insurance
Quick Apply
TikTok Shop - External Affairs Manager
TikTok —Seattle, WA
- $103,360 - $209,380 a year
- Office
- 3 years
- Analysis skills
- Paid parental leave
- Paid holidays
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
Research Operations Program Manager
Veteran Affairs —Seattle, WA
- $83,322.84 - $106,367.29 a year
- Full-time
- 5 years
- Bachelor of Science
- Master's degree
Quick Apply
11d
NODES Research Nurse Veterans Affairs (VA) Cooperative Studies Program
Veteran Affairs —Seattle, WA
- $87,000 - $140,000 a year
- Full-time
- Background check
- Nursing
- RN License
- Health insurance
- Dental insurance
Quick Apply
Scientist I, Analytical Sciences - Mass Spec
Omeros Corporation —Seattle, WA
- $105,000 - $130,000 a year
- Email
- Bachelor of Science
- Microsoft Office
- Bachelor's degree
- Paid holidays
- Health insurance

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Regulatory Affairs Associate II

INBIOS INTERNATIONAL INC -
Seattle, WA

Quick Apply

Job Details

Full-time
$91,500 - $125,000 a year
4 days ago

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Vision insurance

Qualifications

FDA submissions
Statistics
Compliance risk assessment
Manufacturing facility experience
Biomedical regulatory compliance
Managing projects
Statistical analysis tools
Assays

Full Job Description

About the Opportunity

We are seeking a highly motivated and detail-oriented Regulatory Affairs professional to join our team. This position supports the development, registration, commercialization, and lifecycle management of innovative in vitro diagnostic (IVD) products designed to address emerging infectious diseases and biothreats.

The ideal candidate has a strong understanding of U.S. and international regulatory requirements for diagnostic products and is experienced in preparing regulatory submissions and supporting cross-functional product development teams. You are proactive, organized, and capable of managing multiple priorities while working collaboratively with scientific, quality, manufacturing, and commercial teams. If you enjoy solving complex regulatory challenges and helping bring impactful diagnostic solutions to market, we encourage you to apply.

This is a regular full-time position that will be supported by project-based funding. The anticipated duration of the funded project is approximately one (1) year. While InBios hopes to retain successful team members beyond the initial project period, continued employment will depend on business needs, project requirements, and the availability of future funding through contract renewals, expanded programs, or new initiatives.

About Us

InBios International Inc. has been advancing diagnostic solutions since 1996, specializing in the design, development, and manufacturing of assays for emerging infectious diseases and biothreats. Our work supports global health initiatives and government-funded programs, with a strong focus on innovation, quality, and compliance.

Based in Seattle, WA, we offer a collaborative, mission-driven culture where employees contribute to meaningful work that impacts lives worldwide.

About the Position

Position Title: Regulatory Affairs Associate II
Location: Seattle, WA
Employment Type: Full-time, exempt | On-site (Hybrid option may be available after employee is established in the position.)
Position Pay Range: $91,500 - $125,000 annually (based on knowledge, skills, and experience)

What You’ll Do

Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
Write/review protocols for analytical studies in support of regulatory submissions.
Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
Support international registrations, create and maintain technical files, and prepare product dossiers.
Prepare and maintain Design History Files.
Lead Risk Management effort.
Prepare and review labeling and marketing materials to ensure regulatory compliance.
Help set the regulatory strategy for new product development.
Keep abreast with the latest regulatory requirements and trends.
Communicate with the FDA and other regulatory bodies concerning product submissions.

What We’re Looking For

Bachelor's or Master's degree in Life Sciences, Bioengineering, Regulatory Affairs, or a related discipline.
Minimum of 5 years of regulatory affairs experience within an FDA-regulated IVD manufacturing environment, or a Ph.D. with at least 2 years of applicable industry experience.
Certification in regulatory affairs preferred.
Excellent knowledge of US and international IVD regulations.
Strong written and verbal communication skills.
High attention to detail.
Technical system skills (e.g., MS Office, SharePoint, statistical packages, online research).
Ability to manage multiple projects and deadlines.
Strong understanding of statistical analysis.
Ability to identify compliance risks and escalate when necessary.
Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for lateral flow and real-time PCR assays is required.

Work Environment

Professional office environment with extensive computer-based work.
Occasional work in a GMP-regulated manufacturing environment and Biosafety Level 2 (BSL-2) laboratory setting.

Perks & Benefits

Medical, dental, vision, life & disability insurance
401(k) + Roth IRA + FSA options
2 weeks paid vacation + 11 paid holidays (including winter break)
Competitive pay and growth opportunities
Supportive, team-oriented culture focused on innovation and impact

Apply Today

Join a dedicated team committed to advancing diagnostic technologies that improve lives worldwide. Bring your regulatory expertise, collaborative mindset, and passion for quality to help deliver innovative solutions for infectious disease detection and global public health.

Quick Apply

Refine Your Search

regulatory affairs jobs in seattle, wa

Regulatory Affairs Associate II

Regulatory Affairs Specialist II

Manager, Regulatory Affairs

Research Associate I

Regulatory & External Affairs Analyst

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Manager, Regulatory Affairs

Regulatory Coordinator I/II - Lab Based Studies

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Director, Clinical Research Quality Assurance and Regulatory Support

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

Senior Director, Clinical Regulatory Affairs

TikTok Shop - External Affairs Manager

Director of Environmental Affairs

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NODES Research Nurse Veterans Affairs (VA) Cooperative Studies Program

Scientist I, Analytical Sciences - Mass Spec

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