IVD Regulatory Affairs Associate II – Submissions

InBios International, Inc.; Seattle (WA); On-site; USD 92,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) + Roth IRA + FSA

Paid vacation & holidays

Growth opportunities

Team-focused culture

Job summary

InBios International, Inc. in Seattle seeks a Regulatory Affairs Associate II to support regulatory submissions, lifecycle management, and compliance for innovative IVD products. The role collaborates with science, quality, manufacturing and commercial teams to navigate evolving regulatory requirements.

The ideal candidate has a thesis-based master’s or Ph.D. in Life Sciences or related field, 3–5 years of FDA-regulated IVD experience, and strong written/verbal communication.

Qualifications

• Thesis-based Master’s or Ph.D. in Life Sciences, Bioengineering, or related field.
• 3–5 years of regulatory affairs experience in FDA-regulated IVD environment.
• Experience with US regulatory submissions (pre-submissions, EUA, 510(k), De Novo).
• Knowledge of EU IVDR and PMS reporting preferred.

Responsibilities

• Lead or represent Regulatory Affairs in product life cycle projects.
• Develop regulatory strategy for new product development and updates.
• Draft and review regulatory protocols for analytical/clinical studies.
• Support regulatory submissions to FDA and international bodies.
• Maintain technical documentation and product dossiers; manage labeling.

Skills

Regulatory affairs

FDA submissions

Attention to detail

Communication skills

Project management

Cross-functional collaboration

Education

Master's or PhD in Life Sciences/Bioengineering

Tools

MS Office

SharePoint

Statistical packages

Job description

InBios International, Inc. in Seattle seeks a Regulatory Affairs Associate II to support regulatory submissions, lifecycle management, and compliance for innovative IVD products. The role collaborates with science, quality, manufacturing and commercial teams to navigate evolving regulatory requirements.

The ideal candidate has a thesis-based master’s or Ph.D. in Life Sciences or related field, 3–5 years of FDA-regulated IVD experience, and strong written/verbal communication.