New · posted Oct 17
InBios International · Medical Devices
Regulatory Affairs Associate II
- Seattle, WA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
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, is experienced in preparing regulatory submissions and supporting cross-functional product development teams and has a thesis-based advanced degree in Life Sciences, Bioengineering, or a related discipline. 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.
- 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.)
- Salary Range: $92,196 - $125,000 annually
Salary range represents the full pay range for the position and is not the anticipated starting salary range. Individual offers are based on relevant experience, skills, qualifications, position requirements, and internal equity. Employees may progress through the range over time as proficiency and experience in the role develop.
Description
What you need
What We’re Looking For
- Thesis-based Master's degree or Ph.D. in Life Sciences, Bioengineering, or a related discipline.
- 3 - 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.
- Prior experience in US regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for IVDs is required.
- Direct experience with EU IVDR Notified Body interactions, technical documentation preparation, and PMS reporting is preferred.
- Excellent knowledge of US and international IVD regulations.
- Strong written and verbal communication skills.
- High attention to detail.
- Computer literacy (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.
- Strong interpersonal skills and the ability to collaborate effectively with a variety of personnel within and outside of the company.
- Hands-on experience with lateral flow assays, real-time PCR, and/or ELISAs is preferred.
What you'll do
- Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
- Assist in the development of regulatory strategy for new product development and update strategy as needed, based upon regulatory changes.
- Write and review protocols for analytical and clinical studies in support of regulatory submissions, and train lab personnel who will perform analytical and clinical studies.
- Support clinical study execution, including IRB submissions, site initiation, site management, and ongoing study coordination.
- Lead the preparation and submission of FDA regulatory submissions, such as pre-submissions, EUAs, 510(k) submissions, and De Novo requests for Class II and Class III products.
- Support international registrations, create and maintain technical documentation, and prepare product dossiers in support of maintaining CE mark on current products and obtaining CE mark on new products.
- Prepare and maintain Design History Files.
- Lead Risk Management and Post-Market Surveillance (PMS) efforts.
- Prepare and review labeling and marketing materials to ensure regulatory compliance.
- Keep abreast of the latest regulatory requirements and trends.
- Communicate with the FDA and other regulatory bodies concerning product submissions.
Pay and benefits
$92,196 – $125,000 a year
Employer providedMedical, dental, vision, life & disability insurance
401(k) + Roth IRA + FSA options
2weeks
2 weeks paid vacation + 11 paid holidays (including winter break)
Competitive pay and growth opportunities
Supportive, team-oriented culture focused on innovation and impact
Where you'll work
Seattle, WAOn-siteOpen in Maps (opens in a new tab)
More jobs in Seattle, WAWorking conditions
- Office environment with extensive computer-based work.
- Occasional work in a GMP-regulated manufacturing environment and Biosafety Level 2 (BSL-2) laboratory setting.
From the posting
About InBios International
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.
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.
Job intelligence
The context around this role
Live data · October 18, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US29 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $92,196 | — | $125,000 |
| All US (middle half) | $84,000 | $92,000 | $95,500 |
This role: InBios International's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 18, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 286 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not InBios International's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions10
- Collaboration and leadership9
- GMP and compliance3
- Lab testing and methods2
- Documentation and SOPs2
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
Company hiring pulse
InBios International on Regulatory Jobs
- 2
- Open roles
- 1
- Distinct roles
- 1
- Locations
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Regulatory Affairs Associate II at InBios International
Open until filled. $92K–$125K a year, employer provided.