Regulatory Affairs Associate II

Job overview

The Regulatory Affairs Associate II is an onsite role in Seattle, WA; a hybrid option may be available after the employee is established in the position. The annual pay range is $91,500–$125,000. The role supports InBios International’s development, registration, commercialization, and lifecycle management of in vitro diagnostic products for emerging infectious diseases and biothreats. The associate contributes regulatory expertise across product development and lifecycle activities, helping prepare submissions, maintain technical documentation, manage risk, and ensure compliant labeling and marketing materials. The position works with scientific, quality, manufacturing, and commercial teams and communicates with the FDA and other regulatory bodies.

What you'll do

• Represent or lead Regulatory Affairs in project teams throughout the product lifecycle. Write or review analytical study protocols supporting submissions
• assist with EUA, pre-submission, and 510(k) submissions
• support international registrations and maintain technical files, product dossiers, and Design History Files. Lead risk management efforts, review labeling and marketing materials for compliance, help set regulatory strategy for new products, monitor regulatory requirements, and communicate with the FDA and other regulatory bodies.

What we're looking for

Skills & competencies

regulatory affairs associate ii

in vitro diagnostics

ivd

regulatory submissions

fda

510(k)

eua

risk management

seattle wa

inbios international

onsite

hybrid option

$91,500–$125,000/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, life, and disability insurance
• 401(k), Roth IRA, and FSA options
• two weeks of paid vacation and 11 paid holidays
• growth opportunities.

Why this role

Regular full-time position supported by project-based funding anticipated to last approximately one year; continued employment depends on business needs, project requirements, and future funding. Hybrid work may be available after the employee is established.

About the employer

INBIOS INTERNATIONAL INC is hiring for this role. Industry: In-Vitro Diagnostic Substance Manufacturing. Sector: 32.