Regulatory Affairs Associate II

InBios International, Inc.; Seattle (WA); Vor Ort; USD 91.500 - 125.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) + Roth IRA + FSA options

Paid vacation & holidays

Competitive pay & growth opportunities

Team-focused culture

Zusammenfassung

InBios International Inc. is seeking a Regulatory Affairs Associate II to support development, registration, and lifecycle management of diagnostic products for emerging infectious diseases. The role focuses on U.S.

and international regulatory submissions, with collaboration across scientific, quality, manufacturing and commercial teams. The ideal candidate brings strong knowledge of FDA-regulated IVDs, experience with 510(k)/EUAs, and the ability to manage multiple projects in a dynamic

Qualifikationen

• Bachelor's or Master's degree in Life Sciences, Regulatory Affairs or related discipline.
• Minimum of 5 years of regulatory affairs experience in FDA-regulated IVD environment, or a PhD with 2+ years.
• Certification in regulatory affairs preferred.

Aufgaben

• Represent and lead Regulatory Affairs in project teams throughout product life cycle.
• Write/review protocols for analytical studies in support of regulatory submissions.
• Assist in 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 efforts.
• Prepare and review labeling and marketing materials for regulatory compliance.
• Help set regulatory strategy for new product development.
• Stay abreast of latest regulatory requirements and trends.
• Communicate with the FDA and other regulatory bodies about submissions.

Kenntnisse

Regulatory affairs

Project management

Communication

Attention to detail

Statistical analysis

Multitasking

Cross-functional collaboration

Ausbildung

Bachelor's degree in Life Sciences/Regulatory Affairs

Master's degree in Life Sciences/Regulatory Affairs

PhD with regulatory experience

Tools

MS Office

SharePoint

Statistical packages

Online research

Jobbeschreibung

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

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.