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Regulatory Affairs Associate Jobs in Renton, WA (NOW HIRING)

Verathon Inc.

Manager, Regulatory Affairs

Bothell, WA · On-site

Partner with the Associate Director to identify staffing needs and contribute to workforce planning. * Own budget planning and tracking for the Regulatory Affairs function, including headcount ...

Philips

Senior Regulatory Affairs Specialist

Bothell, WA · On-site

$105K - $168K/yr

Job TitleSenior Regulatory Affairs Specialist Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and ...

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How much do regulatory affairs associate jobs pay per hour?

As of Jul 29, 2026, the average hourly pay for regulatory affairs associate in Renton, WA is $44.68, according to ZipRecruiter salary data. Most workers in this role earn between $35.82 and $52.93 per hour, depending on experience, location, and employer.

What Is a Regulatory Affairs Associate?

A regulatory affairs associate helps medical and pharmaceutical companies navigate regulatory approval processes so that products conform to all local, state, and federal regulations. As a regulatory affairs associate, you work with a team to obtain approval for products, maintain database systems for relevant information, and create reports required by federal or government agencies. You stay abreast of developments in legislation and regulation that may affect your company, and advise others on best practices for product development within a regulated framework.

What are Regulatory Affairs Associates?

Regulatory Affairs Associates are professionals who help ensure that companies comply with all regulations and laws applicable to their products, particularly in industries like pharmaceuticals, medical devices, and biotechnology. They are responsible for preparing and submitting documentation to regulatory agencies, maintaining records, and assisting with product approvals. Their work is crucial for bringing safe and effective products to market while meeting all legal requirements.

What are some common challenges Regulatory Affairs Associates face when coordinating with cross-functional teams?

Regulatory Affairs Associates often collaborate closely with departments such as research and development, quality assurance, and marketing. A common challenge is ensuring all stakeholders understand and adhere to regulatory requirements, which may change frequently. Balancing project timelines with the need for accurate and compliant documentation can also be demanding, especially when teams have competing priorities. Effective communication and proactive planning are key to navigating these challenges successfully.

What are the key skills and qualifications needed to thrive as a Regulatory Affairs Associate, and why are they important?

To thrive as a Regulatory Affairs Associate, you need a solid background in life sciences or related fields, attention to detail, and knowledge of regulatory guidelines and standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong organizational skills, effective communication, and the ability to work collaboratively are important soft skills in this role. These abilities ensure accurate documentation, timely regulatory submissions, and successful navigation of complex compliance requirements.
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Regulatory Affairs Associate jobs near you
Infographic showing various Regulatory Affairs Associate job openings in Renton, WA as of July 2026, with employment types broken down into 77% Full Time, 19% Part Time, 1% Temporary, and 3% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $92,944 per year, or $44.7 per hour.

Regulatory Affairs Associate II

INBIOS INTERNATIONAL INC

Seattle, WA • On-site, Remote

$91K - $125K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Job description

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. 

Apply