Regulatory Affairs Associate II - IVD Diagnostics (Hybrid)

InBios International, Inc.; Seattle (WA); On-site; USD 91,500 - 125,000; Full time

Benefits offered by this job

Health insurance

401(k) + Roth IRA + FSA options

Paid vacation & holidays

Competitive pay & growth opportunities

Team-focused culture

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Project management

Communication

Attention to detail

Statistical analysis

Multitasking

Cross-functional collaboration

Education

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

Job description

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